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. 6601N model consists of a 10/0 Nylon suture of length 15cm attached with one 150 microns SS needles having the needle length of 5.6mm in one end of suture. Angle of curvature of the needle is 160° [1/2 Circle]. Point profile of needle is Spatula. FDA UDI
- Model / Reference
- 6601N FDA UDI
- Description
- Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Nylon suture. 6601N model consists of a 10/0 Nylon suture of length 15cm attached with one 150 microns SS needles having the needle length of 5.6mm in one end of suture. Angle of curvature of the needle is 160° [1/2 Circle]. Point profile of needle is Spatula. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00803878028820 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.
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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 73419464-4760-40d0-84f8-5278b24763f3 36 fields · synced May 30, 2026