Ctbwf-2224
Ref CTBWF-2224
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number10190886231920 | Date27 Mar 2025 | StatusListed |
| European Union | CE/MDR EUDAMED | Number0190886MetalTubesKR 10190886231920 | Date16 Sep 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic name
- Orthodontic tube
- Device name
- Orthodontic Tubes
- Model / reference
- CTBWF-2224
- Primary DI / UDI-DI
- 10190886231920
- Basic UDI-DI
- 0190886MetalTubesKR
- Unit of use DI
- 00190886231923
- FDA product code
- DZD
- EMDN code
- Q010403 Orthodontic brackets and buttons
- GMDN term
- Orthodontic tube
- Device class
- Class IIa EUDAMEDClass I GUDID
- Regulation number
- 872.5410
- EU registration type
- Standard device
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIa | Class I |
Other devices from G&H Wire Company, Inc.
Properties
Other properties (20)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Serial number: No
- Expiration date: No