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. These needles are produced in different lengths likely 5.6 mm, 6.2mm, and 6.0mm etc having the suture diameter of 1-0 to 10-0 respectively. FDA UDI
- Model / Reference
- 6401N FDA UDI
- Description
- Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Nylon suture. These needles are produced in different lengths likely 5.6 mm, 6.2mm, and 6.0mm etc having the suture diameter of 1-0 to 10-0 respectively. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00803878030045 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
Aurolon 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
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 ea80fe4d-1ac5-4ca3-88bc-58cdff09ac5e 36 fields · synced Jun 1, 2026