Identity
- Trade Name
- Aurolon FDA UDI
- Generic Name
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
- Device Name
- Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Nylon suture. 6602N model consists of a 10/0 Nylon suture of length 30cm attached with two 150 microns SS needles having the needle length of 5.6mm in both the ends of suture. Angle of curvature of both the needles are 160° [1/2 Circle]. Point profile of both needles are Spatula. FDA UDI
- Model / Reference
- 6602N FDA UDI
- Description
- Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Nylon suture. 6602N model consists of a 10/0 Nylon suture of length 30cm attached with two 150 microns SS needles having the needle length of 5.6mm in both the ends of suture. Angle of curvature of both the needles are 160° [1/2 Circle]. Point profile of both needles are Spatula. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00803878028837 FDA UDI
- 510(k) Number
- K024090 FDA UDI
- FDA Product Code
- GAR FDA UDI
- GMDN Term
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5020 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
A high-quality non-absorbable ophthalmic suture needle used in general plastic surgery, providing temporary wound support until the wound sufficiently heals.
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
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 083d2c45-44f3-41cb-85c2-e45262842b6d 36 fields · synced Jul 11, 2026