Polyform™ M0068402580
Polyform™ M0068402580 is a Class II device made by Boston Scientific, listed in FDA GUDID since 24 Sep 2015 (UDI-DI 08714729839224), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08714729839224 | Date24 Sep 2015 | StatusListed |
Official records
- AccessGUDID record 08714729839224
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Polyform™
- Generic name
- Pelvic organ prolapse surgical mesh, synthetic polymer
- Model / reference
- M0068402580
- Primary DI / UDI-DI
- 08714729839224
- FDA product code
- OTO
- GMDN term
- Pelvic organ prolapse surgical mesh, synthetic polymer
- Device class
- Class II
- Regulation number
- 878.3300
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code OTO (Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed).
- RESTORELLE Y CONTOUR MESH by Coloplast A/S
- ARTISYN Y-SHAPED MESH by Ethicon Inc.
- RESTORELLE POLYPROPYLENE Y MESH by Coloplast A/S
- ALYTE Y-MESH GRAFT by C. R. Bard, Inc.
- Vertessa Lite Y-Mesh by CALDERA MEDICAL, INC.
- VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH by CALDERA MEDICAL, INC.
- Minimesh Polypropylene Mesh by Mpathy Medical Devices, Ltd.
- Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015 by Coloplast Corp.
- Modification to: Minimesh Polypropylene Mesh by Mpathy Medical Devices, Ltd.