DemeBOND PB12X2402
DemeBOND PB12X2402 is a Class II device made by DemeTECH Corp, cleared under FDA 510(k) K023030 on 18 Jun 2003 and listed in FDA GUDID since 16 Jul 2019 (UDI-DI 10652927421177), 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 | Number10652927421177 | Date16 Jul 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK023030 | Date18 Jun 2003 | StatusActive |
Official records
- AccessGUDID record 10652927421177
- FDA 510(k) database K023030
Across registries
- FDA 510(k) K023030 decided 18 Jun 2003 Active
- FDA GUDID UDI-DI 10652927421177 listed 16 Jul 2019 Listed
Timeline
- Cleared FDA 510(k) K023030
- Listed FDA GUDID 10652927421177
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DemeBOND
- Generic name
- Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
- Model / reference
- PB12X2402
- Primary DI / UDI-DI
- 10652927421177
- 510(k) Number
- FDA product code
- GAT
- GMDN term
- Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
- Device class
- Class II
- Regulation number
- 878.5000
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Polyester suture, non-bioabsorbable, multifilament.
- Graft Fixation System 20056S by PARCUS MEDICAL LLC
- Graft Fixation System 20055 by PARCUS MEDICAL LLC
- FSSB A017PEG by Surgical Specialties México, S. de R.L. de C.V.
- FUMEDICA H26-2723N by Surgical Specialties México, S. de R.L. de C.V.
- FortiTex Suture, USP #2, blue, needle 100.356 by 41medical AG
- TEVDEK IPN928577 LSI-100009 by TELEFLEX INCORPORATED