Identity
- Trade Name
- Polycryl FDA UDI
- Generic Name
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
- Device Name
- Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and PGA suture. A6409 model consists of a 6/0 PGA suture of length 45cm attached with two 510 microns SS needles having the needle length of 20.0mm in one end of suture. Angle of curvature of both the needles are 135° [3/8 Circle]. Point profile of needle is Conventional Cutting. FDA UDI
- Model / Reference
- A6409 FDA UDI
- Description
- Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and PGA suture. A6409 model consists of a 6/0 PGA suture of length 45cm attached with two 510 microns SS needles having the needle length of 20.0mm in one end of suture. Angle of curvature of both the needles are 135° [3/8 Circle]. Point profile of needle is Conventional Cutting. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00803878029032 FDA UDI
- 510(k) Number
- K140039 FDA UDI
- FDA Product Code
- GAM FDA UDI
- GMDN Term
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4493 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: Nylon suture, non-bioabsorbable, monofilament
Polycryl by Aurolab — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nylon suture, non-bioabsorbable, monofilament.
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- SUPRAMID — S. Jackson, Inc. · Class II
- ETHILON — Ethicon Inc. · Class II
- UNIFY Nylon Surgical Sutures — APPLIED DENTAL, INC. · Class II
- DemeLON — DemeTECH Corp · Class II
Cleared under the same submission
K140039 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 48792361-d38b-480c-8d94-2a290643efa3 35 fields · synced Jun 6, 2026