SUTURES. 9 Circuit Drive Hendon SA 5014 AUSTRALIA

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1 D Y N E K SUTURES G L O B A L Marketing Division, Manufacturing Facility & Orders 9 Circuit Drive Hendon SA 5014 AUSTRALIA Postal Address PO Box 2346 Port Adelaide SA 5015 Telephone Facsimile export@dynek.com D Y N E K P T Y L T D ABN WHOLLY AUSTRALIAN OWNED COMPANY Dynek Sutures manufactured to ISO CE marked Dynek Pty Ltd. BE THE SYMBOL OF TECHNICAL EXCELLENCE

2 No Compromise in pursuit of excellence No compromise in Procedures, Equipment or Supplies. Dynek sutures are made to uncompromising standards with proven performance in many fields of surgery: Plastic Micro Ophthalmic General O & G Cardiovascular Thoracic Orthopaedic E.N.T. Neuro Orthodontic At Dynek, Quality is placed above all other considerations. EC certified by SGS UK Ltd CE mark 0120 Manufacture to EC council directive 93/42/EEC Manufacture to ISO Quality Standard AQIS approved laboratory state of the art laboratory... Dynek Pty Ltd the company Few professions are as demanding as modern medicine. From the skilled hands of the surgeon to the exacting duties of the operating theatre staff surgery offers no room for compromise. This understanding of commitment to Quality is the driving force behind The Southern Hemisphere s leading supplier of surgical sutures; Dynek Pty Ltd. Dynek is proudly Australian owned. Its state of the art manufacturing facility is situated in Adelaide, the capital of South Australia, and is CE Mark certified CE0120 with SGS UK Ltd. The company has been manufacturing quality sutures in South Australia since 1974 and during this time has not remained inward looking; instead, a commitment to achieving the highest standards has prevailed, ensuring dynamic growth and world class status as a supplier of the best surgical products. Dynek understands the unique needs of the medical profession and Dynek s fine surgical products exists as a result of close ongoing consultation with medical professionals, and the knowledge gained through meticulous research and development. Arising from this strong foundation, Dynek has established a reputation for innovative product development and marketing, and today, supplies in excess of 2000 different kinds of single use absorbable and nonabsorbable sutures. Dynek is the only wholly Australian owned suture company.

Dynek described Dynek is an equal opportunity employer; driven by a one level management system with a commitment to staff training and further education.

3 Dynek described Dynek is an equal opportunity employer; driven by a one level management system with a commitment to staff training and further education. A responsible team of professionals sensitive to environmental issues while focused on a common goal; the research and development of a world class product. Dynek mission statement A History of research, commitment and successful innovation Dynek s success has been widely acclaimed in Australia. Renowned for its technical excellence, Dynek has produced a world class range of sutures, now exported around the globe. With production running into millions of sutures each year, Dynek looked to the future when investing in a new state of the art manufacturing facility. This facility, along with advances in micro engineering, has enhanced productivity and enabled the attainment of ISO13485 & CE Mark Accreditation. In recent years, research and development has expanded into many new areas. Dynek recognises that although research absorbs large amounts of capital, the benefits to the medical profession and most importantly, the patient, are of paramount importance. Environmental concerns are foremost in people s minds. Dynek is committed to ensuring that where possible, all products can be recycled or destroyed without harmful residue. A company s greatest assets are the ideas and the visions of its employees. Dynek could not have achieved such advancements in technology without the proven performance of a well trained and dedicated team. The strength of this company is its people and their ongoing commitment to quality and service. We are committed to being the leading supplier of quality world class products in our field. Consistently providing a level of quality and reliability of supply, that will equal or surpass the expectations of our most critical customer. Proudly, our product is a result of ongoing research and development, providing long term benefits to the medical profession and most importantly the patient. Dynek privacy policy statement Privacy Policy Objective - To ensure customers and Dynek Pty Ltd Personnel understand their rights and obligations with regard to preserving the privacy of our customers. Privacy Statement - It is Dynek Pty Ltd intention to provide its customers with absolute confidence that all details recorded by Dynek during the course of normal business operations are accorded the utmost confidentiality and that the full privacy of the customer is maintained at all times.

Quality the first word in our product The Dynek team is totally committed to the successful implementation and maintenance of Total Quality Control.

Briefly, Dynek s Quality Assurance Programme is executed by: The employment of a team of Microbiologists to oversee Quality procedures.

4 Quality the first word in our product The Dynek team is totally committed to the successful implementation and maintenance of Total Quality Control. Quality goals are achieved by the development and constant refining of Standard Operating Procedures, thorough training, and continuous personnel education. Briefly, Dynek s Quality Assurance Programme is executed by: The employment of a team of Microbiologists to oversee Quality procedures. The validation of all incoming material to documented Quality standards. Ongoing Quality control checks made on all aspects of suture manufacture. Strict testing procedures carried out to exacting Quality standards. The commitment of all personnel to support the company mandate to achieve, at all times, Quality in excess of that specified by world standards. Dynek sutures are manufactured to Standard ISO Dynek is a company in which Total Quality Control is placed above all other considerations, a company whose primary task is absolute customer satisfaction and confidence in a product manufactured with pride under the Dynek trademark. Needle specifications include: reverse conventional Fineline* straight cutting round bodied taper Lancet-Spatula A-cute* taper reverse premium cutting point Threads range from: plain catgut chromic catgut silk nylon polyether polyester polyvinylidene fluoride(pvdf) polyglycolide others available on request

5 DYNEK SUTURE MATERIALS AND TRADEMARKS Absorbable Sutures CODE PRODUCT MATERIAL CG No Trademark Chromic Catgut PG No Trademark Plain Catgut B BIOVEK* Violet Braided Coated Polyglycolide Synthetic Absorbable B-C BIOVEK* UNDYED Beige Braided Coated Polyglycolide Synthetic Absorbable Non Absorbable Sutures CODE PRODUCT MATERIAL V VILENE* Blue Monofilament Polyvinylidene Fluoride N NYLENE* Blue Monofilament Nylon D DYLOC* Blue Monofilament Polyether S DYSILK* Black Braided Treated Silk P-S DYFLEX* Green Braided Treated Polyester P POLYFLEX* Black Braided Treated Polyester T TEFLEX* White Braided Treated Polyester R RADENE* Yellow Monofilament Polyvinylidene Fluoride SS DYCROM* Monofilament Stainless Steel Wire Other non suture CODE PRODUCT DESCRIPTION FINELINE* A-CUTE* TAPER Dermaloc* Needle Needle Skin Tone wound closure strips IMPORTANT: Dynek sutures are single use only devices and should not be re-sterilised The information contained in this catalogue is intended as a guide only. The final decision on suture selection and subsequent use remains the Surgeon s. ** TRADEMARK DYNEK Research and Development leads to continuous improvement and replacement of products, and we therefore reserve the right to make changes to specifications without notice.

6 HOW TO INTERPRET DYNEK CODE NUMBERS Code numbering is very important in the stock control and selection of sutures. There are many different types, and this can make the choice difficult. We believe that codes must be kept simple and should be easy to decipher. Needle Type Lift & Tear Thread Type Thread Size Length of Thread Single Use Only Lot No. Instructions For Use Expiry Date A: Refers to the Suture Material B: Suture USP C: Needle Number in Catalogue The codes convey three pieces of information: A. The first letter(s) refer to the material. B. The next number(s) refer to the USP thread size. C. The final number(s) refer to the needle code. * If #1 precedes the thread size, this indicates a longer thread length than the standard. For example, N-306 has a 45cm thread, where N-1306 has a cm thread. Pre-cut Lengths: Pre-cut lengths of sutures also have an easy to understand coding system. Please remember that the second letter of the code is equal to its numerical partner, i.e. A equals one strand; B equals two strands; C equals three strands etc. The first number(s) indicate the USP thread size. The last two numbers represent the thread length in inches eg: SM4024 = Silk x 13 strands size USP 4/0 x 24 inches in length. Once the coding is understood it is possible to use the code without the catalogue. In a teaching hospital it is good practice for staff to be able to explain what they are using and how they selected it. SYMBOL: The Symbol on the foil packet indicates the needle type eg: = round bodied taper needle, = reverse cutting needle DOUBLE ARMED: Double armed sutures have two symbols ( in the foil packet. ) next to the needle profile, to note two needles are

PACKAGING INFORMATION Packaging: The packaging of sutures is very important to everyone. Consequently, Dynek has developed a suture packet which is easy to use.

7 PACKAGING INFORMATION Packaging: The packaging of sutures is very important to everyone. Consequently, Dynek has developed a suture packet which is easy to use. All Dynek sutures are colour coded using the internationally accepted system, which allows easy transition from one brand to another. The Dynek primary foil packs are quick and easy to open revealing the needle locked in place to help prevent needle stick injury. Expiry Dates: To minimise stock holding, every Dynek primary pack and box label has the expiry date clearly shown. This provides the Operating Room Staff the ability to issue the sutures to other areas. Lot Numbers: Every Dynek foil and label is clearly marked with the lot number. Each lot number allows the product to be traced through every step of production, ensuring maximum manufacturing control and traceability.

8 PACKAGING INFORMATION Standards for Diameter: Specifications for Absorbable Catgut Sutures Specifications for Non-Absorbable Sutures USP METRIC DIAMETER (MM) USP METRIC DIAMETER (MM) SIZE SIZE MINIMUM MAXIMUM SIZE SIZE MINIMUM MAXIMUM 8/ / / / / / / / / / / / / / / / and Specifications for Stainless Steel Sutures Specifications for Synthetic Absorbable Sutures USP METRIC DIAMETER (MM) USP METRIC DIAMETER (MM) SIZE SIZE MINIMUM MAXIMUM SIZE SIZE MINIMUM MAXIMUM 2/ / / / / and / / / / / and

9 SPECIFICATIONS Types and Suggested Uses A-CUTE* TAPER Flat shanked round-bodied needle constructed from a new series stainless steel, with an especially sharp cutting tip that allows for easier penetration through hardened or calcified tissue. The needle is frequently used in cardiovascular and dental surgery. CARDIO CUTTING POINT A fine, flat-shanked round bodied taper needle with a specially designed, sharp cutting point. This needle has been uniquely constructed for use in cardiovascular surgery to minimise the impact of the needle penetration on tissue trauma. The flat shanked body ensures that the needle is held securely in the needle holder. ROUND BODIED TAPER BLUNT POINT This flat shanked round bodied taper needle is ideal for soft, easily penetrated tissues. A range of bluntpoint needles are available for intestinal (liver) surgery. REVERSE PREMIUM CUTTING POINT A special hand-finished extremely sharp reverse cutting needle designed for delicate tissue and ideal for plastic surgery. REVERSE CUTTING FINELINE* CONVENTIONAL CUTTING LANCET - SPATULA A triangular reverse cutting needle, it is strong, retains it sharpness and is considerably more resistant to bending than the standard conventional needle. A flat-shanked plastic surgery needle designed for increased stability in the needle holder to permit accurate placement through the tissue. The conventional cutting point produces an excellent result in cosmetic surgery. A triangular cutting needle with the third cutting edge on its inside apex. This square shanked, side cutting needle offers extra sharpness and penetration, and is commonly used in ophthalmic surgery. SILICONISED CV300 The majority of cutting needles are silicone treated to increase penetration. Dynek s world leading CV300 needles for cardiovascular surgery have been developed to achieve extra penetration and a high bending resistance yet flexible when bent. Important : As the range of needles is continually expanding, if the needle you require is not listed, please ask a Dynek suture consultant.

10 SELECTION REVERSE CUTTING S 1/2 Circle REVERSE CUTTING LENGTH (MM) 15 16MM 14 18MM 34 25MM 90 60MM REVERSE PREMIUM CUTTING POINT S 1/2 Circle REVERSE PREMIUM CUTTING POINT LENGTH (MM) 16 15MM 3/8 Circle REVERSE PREMIUM CUTTING POINT 2D 11MM 49 13MM 3/8 Circle REVERSE CUTTING 2 12MM 24 16MM 40 13MM 20 18MM 4 16MM 3 20MM MM 24MM 21 24MM 47 26MM 8 26MM MM 30MM FINELINE* CUTTING S 3/8 Circle FINELINE* CUTTING 25 LENGTH (MM) 16MM 31 35MM 26 20MM 13 40MM 27 25MM 10 45MM

11 SELECTION CONVENTIONAL CUTTING S 1/2 Circle CONVENTIONAL CUTTING ROUND BODIED TAPER S 1/2 Circle ROUND BODIED TAPER CV300 LENGTH (MM) LENGTH (MM) 18 22MM 51 10MM 3/8 Circle CONVENTIONAL CUTTING 11 90MM MM 16MM 18MM 65 20MM 68 25MM A-CUTE* TAPER S 1/2 Circle A-CUTE* TAPER 35 LENGTH (MM) 18MM MM 35MM 58 20MM 97 40MM 32 25MM 98 48MM 42 35MM 85 65MM MM 55MM 86 MM 1/2 Circle ROUND BODIED TAPER HEAVY 3/8 Circle A-CUTE* TAPER 63 18MM 70E5 97E5 35MM 40MM 98E5 48MM

12 SELECTION 1/4 Circle ROUND BODIED TAPER CV MM 0.15MM 71 25MM J TYPE ROUND BODIED TAPER CV MM MM 0.15MM MM 0.20MM MM 0.23MM 3/8 Circle ROUND BODIED TAPER CV300 LENGTH (MM) 52 10MM 53 13MM LANCET-SPATULA S 3/8 Circle LANCET SPATULA LENGTH (MM) DIAM (MM) MM 0.15MM 54 16MM MM 0.20MM MM 20MM 25MM 30MM MM 0.15MM MM 0.20MM MM 0.35MM 1/2 Circle LANCET SPATULA MM 0.30MM 1/4 Circle LANCET SPATULA STRAIGHT CUTTING S LENGTH (MM) 30 60MM MM 0.30MM CARDIO POINT S 3/8 Circle CARDIO POINT LENGTH (MM) DIAM (MM) MM MM 0.25MM MM 0.25MM MICRO S 3/8 Circle ROUND BODIED TAPER LENGTH (MM) DIAM (MM) Other Needles Available on Special Request MM 0.05MM MM 0.07MM MM 0.10MM

the Proprietary coating formulation used on Biovek* sutures minimises tissue reaction.

13 BIOVEK* AUSTRALIA BIOVEK* Dynek s braided synthetic absorbable suture that delivers the ease-of-use surgeons expect from a braided suture. Biovek* a coated polyglycolide suture is available in a dyed and undyed thread and maintains 70% of its tensile strength in situ for 14 days.the Proprietary coating formulation used on Biovek* sutures minimises tissue reaction. Tensile Strength Retention 70% at 14 days 50% at 21 days Less than 10% at 28 days Generic Formulation Polyglycolide with a coating of Polycaprolactone + Calcium Stearate Method of Absorption Hydrolysis Sterilisation Method Ethylene Oxide (ETO) Colours Dyed(violet) and undyed(beige) FDA-approved colour additives D&C Violet NO 2 are used USP Sizes 5-7/0 on a comprehensive range of needle sizes and types and as pre-cut lengths, 7/0-10/0 on microsurgery needles Requirements Meets all United States pharmacopoeia (USP) and European Pharmacopoeia (EP) requirements for synthetic absorbable surgical sutures, except diameter which meets EP requirements only.

14 BIOVEK* MULTIFILAMENT COATED SYNTHETIC ABSORBABLE DESCRIPTION 6/0 5/0 4/0 3/0 2/ THREAD SIZE USP METRIC ROUND BODIED TAPER LENGTH (cm) SUGGESTED USE 64 AB6064 AB5064 Urological 18mm 1/2 Circle 65 AB5065 AB4065 AB3065 Urological 20mm 1/2 Circle 68 AB4068 AB3068 AB2068 AB068 Gastro/ Intestinal/ 25mm 1/2 Circle 69 AB3069 AB2069 AB069 Gastro/ Intestinal/ 90 AB mm 1/2 Circle 70 AB3070 AB2070 AB070 AB170 Gastro/ Intestinal/ 35mm 1/2 Circle 90 AB12070 AB AB2097 AB097 AB197 AB297 Gastro/ Intestinal/ 40mm 1/2 Circle 90 AB12097 AB1097 AB mm 1/2 Circle 66 AB098 AB198 AB AB1198 Gastro/ Intestinal/ AB3066 Urological 18mm 3/8 Circle Available in E5 Heavy Profile

15 BIOVEK* MULTIFILAMENT COATED SYNTHETIC ABSORBABLE DESCRIPTION 4/0 3/0 2/ THREAD SIZE USP METRIC LENGTH (cm) ROUND BODIED TAPER (HEAVY) SUGGESTED USE 70E5 35mm 1/2 Circle 90 AB3070E5 AB2070E5 AB070E5 AB170E5 AB12070E5 AB1070E5 Gastro/ Intestinal/ 97E5 AB2097E5 AB097E5 AB197E5 AB297E5 Gastro/ Intestinal/ 40mm 1/2 Circle 98E5 AB098E5 AB198E5 AB298E5 Gastro/ Intestinal/ 48mm 1/2 Circle STERILE LENGTHS - NON 100 ABA4040 ABA3040 ABA2040 ABA040 ABA140 Pre cut Lengths 150 ABA4060 ABA3060 ABA2060 ABA060 ABA160 ABA260 Pre cut Lengths 180 ABA3072 ABA2072 ABA072 ABA172 Pre cut Lengths 5X60 ABE4024 ABE3024 ABE2024 ABE024 ABE124 Pre cut Lengths 13X60 ABM4024 ABM3024 ABM2024 ABM024 ABM124 Pre cut Lengths * A minimum order quantity may apply to this product E5 Heavy Profile

16 BIOVEK* MULTIFILAMENT COATED SYNTHETIC ABSORBABLE DESCRIPTION 6/0 5/0 4/0 3/0 2/0 0 1 THREAD SIZE USP METRIC LENGTH (cm) SUGGESTED USE REVERSE CUTTING ADB601 Strabismus 10mm 3/8 Circle 6 45 AB406 AB306 AB1406C clear AB1306C clear AB1206C clear Skin/ Subcuticular 24mm 3/8 Circle 90 AB406CS clear AB306CS clear AB406CS clear 47 26mm 3/8 Circle 45 AB3047 AB13047C Clear Plastic/ Subcuticular 31 35mm 3/8 Circle 45 AB2031 AB12031 AB1131C Clear Skin/ Subcuticular 17E5 45 AB2017E5 AB017E5 Skin/ Subcuticular 35mm 1/2 Circle 12 AB12012 AB1012 Skin/ Subcuticular 40mm 1/2 Circle 90 AB2012S AB012S

17 BIOVEK* MULTIFILAMENT COATED SYNTHETIC ABSORBABLE DESCRIPTION 8/0 7/0 6/0 5/ THREAD SIZE USP METRIC LENGTH (cm) SUGGESTED USE OPHTHALMIC LANCET SPATULA S GDB8F6411* GDB7F6411* Ophthalmic 6.4mm 3/8 Circle (Wire Size 0.20mm) GDB6E8023* Ophthalmic 8.0mm 1/2 Circle (Wire Size 0.30) GDB6F8520* Ophthalmic 8.5mm 1/4 Circle (Wire Size 0.30mm) MICRO S ROUND BODIED TAPER 805 GB6H805* Cardiovascular 8mm 3/8 Circle (Wire Size 0.23mm) 806 LENGTH (cm) GB5H806* SUGGESTED USE Cardiovascular 8mm 3/8 Circle (Wire Size 0.30mm) * A minimum order quantity may apply to this product

Presented by LINXObere Medizintechnik GmbHH

Advanced Wound Closure Solutions By LINXOBERE Surgical Products Presented by LINXObere Medizintechnik GmbHH Needle Type Structure Symbol Main Applications Round Needles (Taper Point) Smallest possible