FITBONE® CEl 120V
by Wittenstein Intens GmbH GUDID
Listed
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04260170143624 | Date17 Apr 2021 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Recalls
No FDA recalls on record, checked 23 Oct 2026.
Specification
- Trade Name
- Fitbone®
- Generic Name
- Distraction implant adjustment remote control
- Model / Ref / Catalog
- CEl 120V, 60001645-00-0
- Primary DI / UDI-DI
- 04260170143624
- FDA Product Code
- HSB
- GMDN Term
- Distraction implant adjustment remote control
- Device Class
- Class II
- Regulation Number
- 888.3020
- GUDID distribution status
- Not in Commercial Distribution
Other devices from Wittenstein Intens GmbH
Properties
Other properties (11)
- 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
- Lot / Batch Number: No
- Expiration Date: No