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. A7102 model consists of a 7/0 PGA suture of length 30cm attached with two 230 microns SS needles having the needle length of 6.5mm in both the ends of suture. Angle of curvature of both the needles are 140° [3/8 Circle]. Point profile of both needles are Spatula. FDA UDI
- Model / Reference
- A7102 FDA UDI
- Description
- Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and PGA suture. A7102 model consists of a 7/0 PGA suture of length 30cm attached with two 230 microns SS needles having the needle length of 6.5mm in both the ends of suture. Angle of curvature of both the needles are 140° [3/8 Circle]. Point profile of both needles are Spatula. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00803878029049 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
Yes
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
MR Safe 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.
- DemeLON — DemeTECH Corp · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- DemeLON — DemeTECH Corp · Class II
- DemeLON — DemeTECH Corp · Class II
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aurolab
Sources (1)
- FDA UDI e548f0a3-f4e2-4402-b66b-741001459b1b 35 fields · synced May 30, 2026