Guided Surgery Key 4.0mm Guided Surgery Key
Guided Surgery Key 4.0mm Guided Surgery Key (0360GSK) is a Class I device made by Oco Biomedical, listed in FDA GUDID since 12 Mar 2024 (UDI-DI D7850360GSK0), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberD7850360GSK0 | Date12 Mar 2024 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Guided Surgery Key
- Generic name
- Surgical drill guide, reusable
- Model / Ref / Catalog
- 4.0mm Guided Surgery Key, 0360GSK
- Primary DI / UDI-DI
- D7850360GSK0
- FDA product code
- NDP
- GMDN term
- Surgical drill guide, reusable
- Device class
- Class I
- Regulation number
- 872.3980
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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