Identity
- Trade Name
- Aurosilk FDA UDI
- Generic Name
- Silk suture FDA UDI
- Device Name
- Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Braided Silk suture. 8481S model consists of a 8/0 Braided Silk suture of length 15cm attached with one 200 microns SS needles having the needle length of 6.0mm in one end of suture. Angle of curvature of the needle is 140° [3/8 Circle]. Point profile of needle is Spatula. FDA UDI
- Model / Reference
- 8481S FDA UDI
- Description
- Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Braided Silk suture. 8481S model consists of a 8/0 Braided Silk suture of length 15cm attached with one 200 microns SS needles having the needle length of 6.0mm in one end of suture. Angle of curvature of the needle is 140° [3/8 Circle]. Point profile of needle is Spatula. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00803878028905 FDA UDI
- 510(k) Number
- K024091 FDA UDI
- FDA Product Code
- GAP FDA UDI
- GMDN Term
- Silk suture FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Silk suture
Aurosilk by Aurolab — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silk suture.
- Sofsilk — Covidien LP · Class II
- PERMA-HAND — Ethicon Inc. · Class II
- DemeSILK — DemeTECH Corp · Class II
- DemeSILK — DemeTECH Corp · Class II
- DemeSILK — DemeTECH Corp · Class II
- Sofsilk — Covidien LP · Class II
- DemeSILK — DemeTECH Corp · Class II
- DemeSILK — DemeTECH Corp · Class II
Cleared under the same submission
K024091 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Aurolab
Sources (1)
- FDA UDI 9d3d411a-0d36-462c-a05a-9ac0082c1a9a 36 fields · synced Jun 6, 2026