Identity
- Trade Name
- DONJOY FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system pack, reusable FDA UDI
- Device Name
- PAD, ELBOW, MANUAL COLD FDA UDI
- Model / Reference
- 11-1317-0-02000 FDA UDI
- Description
- PAD, ELBOW, MANUAL COLD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888912158046 FDA UDI
- FDA Product Code
- ILO FDA UDI
- GMDN Term
- Circulating-fluid localized thermal therapy system pack, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5720 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
Yes
FDA UDI
Donjoy by Djo, Llc — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Djo, Llc
Sources (1)
- FDA UDI 5badf9bc-42c6-4c0c-a8be-7cf346fc8e79 34 fields · synced Jun 1, 2026