rainbow shine SH9812A2
by Genoss
rainbow shine SH9812A2 is a Class II device made by Genoss, cleared under FDA 510(k) K160079 on 10 Nov 2016 and listed in FDA GUDID since 20 Dec 2017 (UDI-DI 08809552960051), 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 | Number08809552960051 | Date20 Dec 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160079 | Date10 Nov 2016 | StatusActive |
Official records
- AccessGUDID record 08809552960051
- FDA 510(k) database K160079
Across registries
- FDA 510(k) K160079 decided 10 Nov 2016 Active
- FDA GUDID UDI-DI 08809552960051 listed 20 Dec 2017 Listed
Timeline
- Cleared FDA 510(k) K160079
- Listed FDA GUDID 08809552960051
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- rainbow shine
- Generic name
- Skin staple remover, reusable
- Model / Ref / Catalog
- SH9812A2
- Primary DI / UDI-DI
- 08809552960051
- 510(k) Number
- FDA product code
- EIH
- GMDN term
- Skin staple remover, reusable
- Device class
- Class II
- Regulation number
- 872.6660
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 98 Millimeter
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