Identity
- Trade Name
- NON FRANCHISE FDA UDI
- Generic Name
- Multiple-joint arm orthosis FDA UDI
- Device Name
- Cryotherm Shoulder Wrap w/4 Gels UNIV FDA UDI
- Model / Reference
- 88-578000727034 FDA UDI
- Description
- Cryotherm Shoulder Wrap w/4 Gels UNIV FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190446704911 FDA UDI
- FDA Product Code
- IQJ FDA UDI
- GMDN Term
- Multiple-joint arm orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 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
Yes
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
Category: Multiple-joint arm orthosis
Non Franchise by Djo, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- PROFIT — PANTYMED S.A. · Class I
- PROFIT — PANTYMED S.A. · 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
- Djo, Llc
Sources (1)
- FDA UDI 765019d7-c96f-4daf-bf08-600d6bf5918b 33 fields · synced May 30, 2026