Na 201.636
by Synthes GUDID
Listed
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10886982142146 | Date14 Sep 2015 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Recalls
-
- Terminated Z-0323-2016
It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System).
-
- 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
- Orthopaedic bone screw (non-sliding)
- Model / Ref / Catalog
- 201.636, 201636
- Primary DI / UDI-DI
- 10886982142146
- FDA Product Code
- HRS, HWC
- GMDN Term
- Orthopaedic bone screw (non-sliding)
- Device Class
- Class II
- Regulation Number
- 888.3030, 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from Synthes
Properties
Other properties (10)
- Sterile: 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