Na 392.179
by Synthes GUDID
Listed
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number20886982198652 | Date14 Sep 2015 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Recalls
-
- Terminated Z-1009-2015
Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating they are MR Safe. They can no longer be labeled MR Safe.
-
- Terminated Z-0406-2014
A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate.
Specification
- Generic Name
- External orthopaedic fixation system noninvasive component, single-use
- Model / Ref / Catalog
- 392.179, 392179
- Primary DI / UDI-DI
- 20886982198652
- FDA Product Code
- MQN, HRS
- GMDN Term
- External orthopaedic fixation system noninvasive component, single-use
- Device Class
- Class II
- Regulation Number
- 872.4760, 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from Synthes
Properties
Other properties (11)
- Sterile: 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