Identity
- Trade Name
- Nova Gel FDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Device Name
- : NovaGel is indicated for use as a scar management dressing on old and new hypertrophic or keloid scars. FDA UDI
- Model / Reference
- GEL-6505 FDA UDI
- Description
- : NovaGel is indicated for use as a scar management dressing on old and new hypertrophic or keloid scars. FDA UDI
Identifiers
- Catalog Number
- GEL-6505 FDA UDI
- Primary DI / UDI-DI
- 00855638007125 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 6 Inch FDA UDI
Category: Scar-management dressing, reusable
Nova Gel by Stellen Medical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Scar-management dressing, reusable.
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- THERAFOAM — BIODERMIS LLC · Class I
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 |
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Manufacturer
- Manufacturer
- Stellen Medical, LLC
Sources (1)
- FDA UDI 6f6a80ba-d5f6-49ca-a416-43d2fa7baaed 37 fields · synced May 30, 2026