Comp Mini Baseplate Depth Gauge SSI008211
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00889024692817 | Date22 Oct 2025 | StatusListed |
Recalls
-
- Terminated Z-0619-2021
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
-
- Terminated Z-0093-2021
Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Comp Mini Baseplate Depth Gauge
- Generic Name
- Surgical depth gauge, reusable
- Model / Ref / Catalog
- SSI008211
- Primary DI / UDI-DI
- 00889024692817
- 510(k) Number
- FDA Product Code
- KWS, PHX
- GMDN Term
- Surgical depth gauge, reusable
- Device Class
- Class II
- Regulation Number
- 888.3660
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from Biomet Orthopedics, Inc.
Properties
Other properties (12)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No