Sterile Trac System 12 Pack Sp-Sta-1841-12
by Biomet Microfixation, Inc 2 variants
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00888233020800 | Date16 Jun 2020 | StatusListed |
Recalls
-
- Terminated Z-0629-2021
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.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Sterile Trac System 12 Pack
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized
- Model / Ref / Catalog
- SP-STA-1841-12
- Primary DI / UDI-DI
- 00888233020800
- 510(k) Number
- FDA Product Code
- JEY, HRS
- GMDN Term
- Craniofacial fixation plate, non-bioabsorbable, non-customized
- Device Class
- Class II
- Regulation Number
- 872.4760, 888.3030
- GUDID distribution status
- In Commercial Distribution
Other devices from Biomet Microfixation, Inc
Properties
Other properties (8)
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No