FISSO Rails Clamp Radial
by Baitella AG Switzerland EUDAMEDGUDID
Ref 5.750-2366Model 3828.xx, 3840.xx, 3855.xx 4840.xx, 4850.xx 5850.xx, 5870.xx 5.75x Product code FWZEMDN V0880
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number07640152573620 | Date15 Jul 2024 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number76401525706OPS7879JG | Date3 Feb 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- FISSO Rails Clamp Radial EUDAMEDFisso GUDID
- Generic Name
- Medical device service rail clamp
- Device Name
- Surgery
- Model / Reference
- 3828.xx, 3840.xx, 3855.xx 4840.xx, 4850.xx 5850.xx, 5870.xx 5.75x, 5.750-2366
- Primary DI / UDI-DI
- 07640152573620
- Basic UDI-DI
- 76401525706OPS7879JG
- Direct Marketing DI
- 07640152573620
- FDA Product Code
- FWZ
- EMDN Code
- V0880 Medical support equipment - accessories
- GMDN Term
- Medical device service rail clamp
- Device Class
- Class I
- Regulation Number
- 878.4950
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Manufacturer details
- EUDAMED SRN
- CH-MF-000017307
- Authorised representative
- Baitella GmbH DE-AR-000014387
Other devices from Baitella AG
Properties & raw data
Show properties, registry sources and raw records
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No
Sources (2)
- EUDAMED 42e91797-9922-4666-945d-8544c3e9237f
- FDA UDI f5ad6628-95c0-4d4a-be7b-6c8a8b476311