TRACOE comfort REF 102-12D
TRACOE comfort REF 102-12D is a Class II device made by Tracoe medical GmbH, cleared under FDA 510(k) K781729 on 24 Oct 1978 and listed in FDA GUDID since 1 Jul 2017 (UDI-DI 04035324005017), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04035324005017 | Date1 Jul 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK781729 | Date24 Oct 1978 | StatusActive |
Official records
- AccessGUDID record 04035324005017
- FDA 510(k) database K781729
Across registries
- FDA 510(k) K781729 decided 24 Oct 1978 Active
- FDA GUDID UDI-DI 04035324005017 listed 1 Jul 2017 Listed
Timeline
- Cleared FDA 510(k) K781729
- Listed FDA GUDID 04035324005017
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TRACOE comfort
- Generic name
- Tracheostomy tube, non-reinforced, non-customized, reusable
- Model / Ref / Catalog
- REF 102-12D
- Primary DI / UDI-DI
- 04035324005017
- 510(k) Number
- FDA product code
- BTO
- GMDN term
- Tracheostomy tube, non-reinforced, non-customized, reusable
- Device class
- Class II
- Regulation number
- 868.5800
- GUDID distribution status
- In Commercial Distribution
- Size
- Lumen/Inner Diameter — 10.8 Millimeter