Gelzone Wrap 5 cm x 30 cm (2 in x12 in)
by Implantech Associates, Inc.
Gelzone Wrap 5 cm x 30 cm (2 in x12 in) (WRAP-212) is a scar-management dressing (FDA Class I; FDA product code MDA, Elastomer, Silicone, For Scar Management) made by Implantech Associates, Inc., cleared under FDA 510(k) K013732 on 7 Feb 2002 and listed in FDA GUDID since 30 Apr 2021 (UDI-DI M724WRAP2121), 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 | NumberM724WRAP2121 | Date30 Apr 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK013732 | Date7 Feb 2002 | StatusActive |
Official records
- FDA 510(k) database K013732
Across registries
- FDA 510(k) K013732 decided 7 Feb 2002 Active
- FDA GUDID UDI-DI M724WRAP2121 listed 30 Apr 2021 Listed
Timeline
- Cleared FDA 510(k) K013732
- Listed FDA GUDID M724WRAP2121
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Gelzone Wrap
- Generic name
- Scar-management dressing, reusable
- Model / Ref / Catalog
- 5 cm x 30 cm (2 in x12 in), WRAP-212
- Primary DI / UDI-DI
- M724WRAP2121
- 510(k) Number
- FDA product code
- MDA
- GMDN term
- Scar-management dressing, reusable
- Device class
- Class I
- Regulation number
- 878.4025
- GUDID distribution status
- In Commercial Distribution
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