Sutumed SDNN001MC480
by Unilene Sac
Sutumed SDNN001MC480 is a Class II device made by Unilene Sac, cleared under FDA 510(k) K123034 on 28 May 2013 and listed in FDA GUDID since 6 Jan 2023 (UDI-DI 07757093013600), active as of 23 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 | Number07757093013600 | Date6 Jan 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123034 | Date28 May 2013 | StatusActive |
Official records
- AccessGUDID record 07757093013600
- FDA 510(k) database K123034
Across registries
- FDA 510(k) K123034 decided 28 May 2013 Active
- FDA GUDID UDI-DI 07757093013600 listed 6 Jan 2023 Listed
Timeline
- Cleared FDA 510(k) K123034
- Listed FDA GUDID 07757093013600
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sutumed
- Generic name
- Nylon suture, non-bioabsorbable, monofilament
- Model / Ref / Catalog
- SDNN001MC480
- Primary DI / UDI-DI
- 07757093013600
- 510(k) Number
- FDA product code
- GAR
- GMDN term
- Nylon suture, non-bioabsorbable, monofilament
- Device class
- Class II
- Regulation number
- 878.5020
- GUDID distribution status
- In Commercial Distribution
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