DemeLENE PM195015F4P
DemeLENE PM195015F4P is a Class II device made by DemeTECH Corp, cleared under FDA 510(k) K043330 on 16 May 2005 and listed in FDA GUDID since 28 Jun 2019 (UDI-DI 10652927315070), 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 | Number10652927315070 | Date28 Jun 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK043330 | Date16 May 2005 | StatusActive |
Official records
- AccessGUDID record 10652927315070
- FDA 510(k) database K043330
Across registries
- FDA 510(k) K043330 decided 16 May 2005 Active
- FDA GUDID UDI-DI 10652927315070 listed 28 Jun 2019 Listed
Timeline
- Cleared FDA 510(k) K043330
- Listed FDA GUDID 10652927315070
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DemeLENE
- Generic name
- Polyolefin/fluoropolymer suture, monofilament
- Model / reference
- PM195015F4P
- Primary DI / UDI-DI
- 10652927315070
- 510(k) Number
- FDA product code
- GAW
- GMDN term
- Polyolefin/fluoropolymer suture, monofilament
- Device class
- Class II
- Regulation number
- 878.5010
- GUDID distribution status
- In Commercial Distribution
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