Identity
- Trade Name
- Avaline Medical NJ LLC FDA UDI
- Generic Name
- Elbow/ankle friction/impact protector FDA UDI
- Device Name
- Knit Heel And Elbow Protector 1 PAIR FDA UDI
- Model / Reference
- HEP1.2 FDA UDI
- Description
- Knit Heel And Elbow Protector 1 PAIR FDA UDI
Identifiers
- Catalog Number
- HEP1.2 FDA UDI
- Primary DI / UDI-DI
- 00653078998368 FDA UDI
- FDA Product Code
- FMP FDA UDI
- GMDN Term
- Elbow/ankle friction/impact protector FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6450 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Avaline Medical NJ LLC by Avaline Medical NJ Limited Liability Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Avaline Medical NJ Limited Liability Company
Sources (1)
- FDA UDI 32b2d09b-e55d-4d89-abd8-01baa01a9d65 36 fields · synced May 30, 2026