Gentrix® LRM0415
by Acell, Inc.
Gentrix® LRM0415 is a Class II device made by Acell, Inc., cleared under FDA 510(k) K040621 on 14 Apr 2004 and listed in FDA GUDID since 19 Jan 2018 (UDI-DI 00386190001752), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | Number00386190001752 | Date19 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK040621 | Date14 Apr 2004 | StatusActive |
Official records
- AccessGUDID record 00386190001752
- FDA 510(k) database K040621
Across registries
- FDA 510(k) K040621 decided 14 Apr 2004 Active
- FDA GUDID UDI-DI 00386190001752 listed 19 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K040621
- Listed FDA GUDID 00386190001752
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Gentrix®
- Generic name
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
- Model / Ref / Catalog
- LRM0415
- Primary DI / UDI-DI
- 00386190001752
- 510(k) Number
- FDA product code
- FTM
- GMDN term
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
- Device class
- Class II
- Regulation number
- 878.3300
- GUDID distribution status
- Not in Commercial Distribution
- MRI safety
- MR Safe
- Size
- Width — 4 CentimeterLength — 15 Centimeter