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. N7202 model consists of a 7/0 Nylon suture of length 30cm attached with two 230 microns SS needles having the needle length of 6.0mm in both the ends of suture. Angle of curvature of both the needles are 140° [3/8 Circle]. Point profile of both needles are Taper point. FDA UDI
- Model / Reference
- N7202 FDA UDI
- Description
- Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Nylon suture. N7202 model consists of a 7/0 Nylon suture of length 30cm attached with two 230 microns SS needles having the needle length of 6.0mm in both the ends of suture. Angle of curvature of both the needles are 140° [3/8 Circle]. Point profile of both needles are Taper point. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00803878029193 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
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
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 d9c8926f-2a11-4294-8ff9-a047650dccdb 36 fields · synced Jun 8, 2026