Identity
- Trade Name
- Gelzone Wrap FDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Device Name
- Hypertrophic and Keloid Scar Management, Joint and Muscle Support/Compression FDA UDI
- Model / Reference
- 25cm x122cm (10 in x48 in) FDA UDI
- Description
- Hypertrophic and Keloid Scar Management, Joint and Muscle Support/Compression FDA UDI
Identifiers
- Catalog Number
- WRAP-1048-NL FDA UDI
- Primary DI / UDI-DI
- M724WRAP1048NL1 FDA UDI
- 510(k) Number
- K013732 FDA UDI
- FDA Product Code
- MDA FDA UDI
- GMDN Term
- Scar-management dressing, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Scar-management dressing, reusable
Gelzone Wrap by Implantech Associates, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K013732 also covers:
- Gelzone Wrap — Implantech Associates, Inc.
- Gelzone Wrap — Implantech Associates, Inc.
- Gelzone Wrap — Implantech Associates, Inc.
- Gelzone Wrap — Implantech Associates, Inc.
- Gelzone Wrap — Implantech Associates, Inc.
- Gelzone Wrap — Implantech Associates, Inc.
- Gelzone Wrap — Implantech Associates, Inc.
- Gelzone Wrap — Implantech Associates, Inc.
- Gelzone Wrap — Implantech Associates, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Implantech Associates, Inc.
Sources (1)
- FDA UDI 3c1513fe-f995-4a80-bed0-aecb3046e25f 36 fields · synced Jun 9, 2026