Identity
- Trade Name
- THERA PLUS FDA UDI
- Generic Name
- Pressure-management bandage, silicone FDA UDI
- Device Name
- ADVANCED HEALING GEL HEEL BANDAGES FDA UDI
- Model / Reference
- 64410153B FDA UDI
- Description
- ADVANCED HEALING GEL HEEL BANDAGES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00049696895927 FDA UDI
- FDA Product Code
- NAC FDA UDI
- GMDN Term
- Pressure-management bandage, silicone FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4018 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
No
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
Category: Pressure-management bandage, silicone
Thera Plus by Fourstar Group Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Fourstar Group Inc.
Sources (1)
- FDA UDI eeee7455-fbfd-40e2-b831-f32d82e6a010 33 fields · synced Jun 1, 2026