Identity
- Trade Name
- PROFIT FDA UDI
- Generic Name
- Wrist/hand orthosis FDA UDI
- Device Name
- BLUE AIR SPORT WRISTBAND - SIZE FDA UDI
- Model / Reference
- 1101-MASZ U M FDA UDI
- Description
- BLUE AIR SPORT WRISTBAND - SIZE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07798128675653 FDA UDI
- FDA Product Code
- IQI FDA UDI
- GMDN Term
- Wrist/hand orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wrist/hand orthosis
Explore the Profit wrist/hand orthosis, a highly effective device for correcting and improving function in individuals with wrist and hand injuries. This reusable appliance is designed to provide support, alignment, and assistance for users, making it an ideal solution for various medical applications.
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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
- Pantymed S.a.
Sources (1)
- FDA UDI 262d24ba-7f7c-448c-9e3f-dbfb9e022feb 33 fields · synced Jul 20, 2026