Soft K-Cot(R) SFT-4200
Soft K-Cot(R) SFT-4200 is a manual wound debridement tool (FDA Class I) made by Histologics, LLC, listed in FDA GUDID since 25 Jul 2021 (UDI-DI 00860275000361), registry data as of 8 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00860275000361 | Date25 Jul 2021 | StatusListed |
Official records
- AccessGUDID record 00860275000361
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Soft K-Cot(R)
- Generic name
- Manual wound debridement tool
- Model / reference
- SFT-4200
- Primary DI / UDI-DI
- 00860275000361
- FDA product code
- FZS, GEE
- GMDN term
- Manual wound debridement tool
- Device class
- Class I
- Regulation number
- 878.4800
- GUDID distribution status
- In Commercial Distribution
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