DemeDIOX PX1080048B1P
DemeDIOX PX1080048B1P is a Class II device made by DemeTECH Corp, cleared under FDA 510(k) K082097 on 8 Jan 2010 and listed in FDA GUDID since 12 Jul 2019 (UDI-DI 10652927219194), 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 | Number10652927219194 | Date12 Jul 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK082097 | Date8 Jan 2010 | StatusActive |
Official records
- AccessGUDID record 10652927219194
- FDA 510(k) database K082097
Across registries
- FDA 510(k) K082097 decided 8 Jan 2010 Active
- FDA GUDID UDI-DI 10652927219194 listed 12 Jul 2019 Listed
Timeline
- Cleared FDA 510(k) K082097
- Listed FDA GUDID 10652927219194
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DemeDIOX
- Generic name
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial
- Model / reference
- PX1080048B1P
- Primary DI / UDI-DI
- 10652927219194
- 510(k) Number
- FDA product code
- NEW
- GMDN term
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial
- Device class
- Class II
- Regulation number
- 878.4840
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Polyester suture, bioabsorbable, monofilament, non-antimicrobial.