Hertra HTR09
by Herniamesh
Hertra HTR09 is a Class II device made by Herniamesh, cleared under FDA 510(k) K973955 on 11 May 1998 and listed in FDA GUDID since 14 Jul 2023 (UDI-DI 58032919891735), 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 | Number58032919891735 | Date14 Jul 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK973955 | Date11 May 1998 | StatusActive |
Official records
- AccessGUDID record 58032919891735
- FDA 510(k) database K973955
Across registries
- FDA 510(k) K973955 decided 11 May 1998 Active
- FDA GUDID UDI-DI 58032919891735 listed 14 Jul 2023 Listed
Timeline
- Cleared FDA 510(k) K973955
- Listed FDA GUDID 58032919891735
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hertra
- Generic name
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
- Model / reference
- HTR09
- Description
- Hertra 9 4.5x10 cm is a macroporous preshaped mesh with keyhole opening, indicated for the treatment of inguinal hernia defects with open technique.
- Primary DI / UDI-DI
- 58032919891735
- 510(k) Number
- FDA product code
- FTL
- GMDN term
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 878.3300
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable.