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DURASIL silk suture is a non absorbable, sterile, surgical suture composed of an organic protein called fibroin.This protein is derived from the domesticated species Bombyx mori B. More of the family Bombycidae. These are processed to remove the natural waxes and gums. DURASIL suture is dyed black and coated with a special wax mixture.Durasil is indicated for use in general soft tissue approximation and/or ligation, including use in Cardiovascular, ophthalmic and neurological procedures..
| Other Specifications Download Specification | |
|---|---|
| Governing Specification | USP 39 |
| Category Of Suture | Non absorbable |
| Construction | Monofilament |
| Suture Material | Black Braided Silk |
| Coating | with coating |
| Coating Material | wax |
| Number Of Strands | 1 |
| Suture Length | 76 cm |
| Needle Length | 30 mm |
| Type Of Needles | Round bodied |
| Needle Curvature | 1/2 circle |
| If Others Then Declare | Nil |
| Sterilised | yes |
| Sterilisation Method | Ethylene Oxide |
| Shelf Life | 5 year |
| No. Of Sutures In A Pack | 12 |
| Sutures Confirming To Provisions Of Drug And Cosmetic Act | YES |
| Date Of Drug Licence | 23.04.2016 |
| Whether Drug License Valid | YES |
| Date Of Non Conviction Certificate | 29.12.2016 |
| To Indicate Whether Holding RGMP Issued Under Revised Schedule-`M' Of Drugs & Cosmetics Act 1940 As Amended Or WHO-GMP(for Manufacturers Only) As Per Norms Amended Up To Date Issued By Licensing Authority Or Other Certifications In Respect Of The OEM. | DCD/CR-445/SPL.Cell-1/2016-2017 |
| Packing As Per Drug Act Provisions And USP | YES |
| Each Packing Shall Be Marked As Under:-a. Nomenclature Of The Stores B. Manufacturers Name, Address, C. Drug License No., D. Month Of Manufacturing, E. Expiry F. Batch No And Lot No (if Applicable) G. Any Other Particulars Required Under Drug Act 1940 Amended Up To Date H. Quantity Contained Therein I. Manufacturers Name Or Trade Mark, | YES |
| Copies Of In House Test Report To Be Forwarded With Each Supply | YES |
| Cartons Shall Be Marked With Manufacturers Name, Batch No And Month Of Manufacture And Use Before. If Indentor Specifies Any Special Marking In Supply Order (eg.CGHS, Railways, CRPF Etc) Same Shall Be Provided. | YES |
| All Packs Must Indicate The Date Of Manufacture And Expiry. In Addition All Supplies Shall Have A Remaining Self Life Of At Least Three - Fourth (3/4th) Of The Stipulated Shelf Life At The Time Of Delivery. | YES |
| If Any Batch Must Be Recalled Because Of Problems With Product Quality Or Adverse Reactions To The Item, The Supplier Will Be Responsible To Notify The Purchaser,reactions To The Item, The Supplier Will Be Responsible To Notify The Purchaser,providing Full Details About The Reason Leading To The Recall And Shall Take Steps To Replace The Product In Question At Its Own Cost With A Fresh Batch Of Acceptable Quality Or Withdraw And Give A Full Refund Of The Value Batch Has Been Taken Off The Market Due To Safety Problems. | YES |
| Test Report From Drug Controller Approved Laboratories Available | YES |
| Test Report Number | B7007 |
| Date Of Issue Of Test Report By Laboratory | 25/08/2017 |
| Name And Address Of Laboratory | SRI ORION PHARMACEUTICALS & SUTURES , No. 138-B, 3rd floor, "Udayagiri complex", 3rd Phase, KIADB Industrial Area, Peenya, Bengaluru |
| Whether Non Conviction Certificate Issued By Drug Authorities Available | YES |
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