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Skin Cooler Roller - SMALL (blue)
FDA UDIClass I (US FDA UDI)
by Fabinject Industria E Comercio Importacao E Exportacao Ltda
Identity
- Trade Name
- Skin Cooler Roller - SMALL (blue) FDA UDI
- Generic Name
- Hot/cold therapy pack, reusable FDA UDI
- Device Name
- Local cooling device for therapeutic procedures. FDA UDI
- Model / Reference
- SCRSMALLBLUEBX01 FDA UDI
- Description
- Local cooling device for therapeutic procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07898493080134 FDA UDI
- FDA Product Code
- IME FDA UDI
- GMDN Term
- Hot/cold therapy pack, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5700 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hot/cold therapy pack, reusable
Skin Cooler Roller - SMALL (blue) by Fabinject Industria E Comercio Importacao E Exportacao Ltda — Class I — FDA UDI — listed in FDA GUDID
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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
Sources (1)
- FDA UDI b940d8b6-8689-4708-a123-438adf53c6af 34 fields · synced May 30, 2026