Demetech PTFE TE1050045A0P
Demetech PTFE TE1050045A0P is a Class II device made by DemeTECH Corp, cleared under FDA 510(k) K181578 on 11 Oct 2018 and listed in FDA GUDID since 9 Jul 2019 (UDI-DI 10652927670537), 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 | Number10652927670537 | Date9 Jul 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181578 | Date11 Oct 2018 | StatusActive |
Official records
- AccessGUDID record 10652927670537
- FDA 510(k) database K181578
Across registries
- FDA 510(k) K181578 decided 11 Oct 2018 Active
- FDA GUDID UDI-DI 10652927670537 listed 9 Jul 2019 Listed
Timeline
- Cleared FDA 510(k) K181578
- Listed FDA GUDID 10652927670537
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Demetech PTFE
- Generic name
- Polyolefin/fluoropolymer suture, monofilament
- Model / reference
- TE1050045A0P
- Primary DI / UDI-DI
- 10652927670537
- 510(k) Number
- FDA product code
- NBY
- GMDN term
- Polyolefin/fluoropolymer suture, monofilament
- Device class
- Class II
- Regulation number
- 878.5035
- GUDID distribution status
- In Commercial Distribution
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