Restorelle 501460
Restorelle 501460 is a Class II device made by Coloplast A/S, listed in FDA GUDID since 22 Oct 2015 (UDI-DI 05708932484084), registry data as of 22 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 | Number05708932484084 | Date22 Oct 2015 | StatusListed |
Official records
- AccessGUDID record 05708932484084
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Restorelle
- Generic name
- Pelvic organ prolapse surgical mesh, synthetic polymer
- Model / Ref / Catalog
- 501460
- Primary DI / UDI-DI
- 05708932484084
- FDA product code
- FTL
- GMDN term
- Pelvic organ prolapse surgical mesh, synthetic polymer
- Device class
- Class II
- Regulation number
- 878.3300
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 14 CentimeterWidth — 15 Centimeter
Similar devices
Other devices filed under FDA product code FTL (Mesh, surgical, polymeric).
- PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH by Ethicon Inc.
- Liora Monofilament Scaffold by TELA Bio, Inc.
- SOFTFORM FACIAL IMPLANT by Tissue Technologies, Inc.
- GORE INFINIT MESH by W. L. Gore & Associates, Inc.
- ALACER SURGICAL SCAFFOLD by Alacer Biomedical, Inc.
- IMMIX PLASTIFILM by Osteobiologics, Inc.
- BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301 by C. R. Bard, Inc.
- SURGI-WRAP MAST BIORESORBABLE SHEET by MAST Biosurgery USA, Inc.
- AUTO SUTURE SURGICAL MESH DEPLOYER by United States Surgical, A Division of Tyco Healthc
- PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH by SOFRADIM PRODUCTION