Polycryl A8104
by Aurolab
Polycryl A8104 is a Class II device made by Aurolab, cleared under FDA 510(k) K140039 on 15 Sep 2014 and listed in FDA GUDID since 16 Sep 2020 (UDI-DI 00803878029063), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00803878029063 | Date16 Sep 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140039 | Date15 Sep 2014 | StatusActive |
Official records
- AccessGUDID record 00803878029063
- FDA 510(k) database K140039
Across registries
- FDA 510(k) K140039 decided 15 Sep 2014 Active
- FDA GUDID UDI-DI 00803878029063 listed 16 Sep 2020 Listed
Timeline
- Cleared FDA 510(k) K140039
- Listed FDA GUDID 00803878029063
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Polycryl
- Generic name
- Nylon suture, non-bioabsorbable, monofilament
- Model / reference
- A8104
- Primary DI / UDI-DI
- 00803878029063
- 510(k) Number
- FDA product code
- GAM
- GMDN term
- Nylon suture, non-bioabsorbable, monofilament
- Device class
- Class II
- Regulation number
- 878.4493
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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