Identity
- Trade Name
- WELLBRACE FDA UDI
- Generic Name
- Lumbar spine orthosis FDA UDI
- Device Name
- FAJA SACROLUMBAR ADVANCE- WELL U 2XL FDA UDI
- Model / Reference
- 1207-FW1 U 2XL FDA UDI
- Description
- FAJA SACROLUMBAR ADVANCE- WELL U 2XL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07798094541617 FDA UDI
- FDA Product Code
- IPY FDA UDI
- GMDN Term
- Lumbar spine 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
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: Lumbar spine orthosis
Wellbrace by Pantymed S.a. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 8e39938f-b4ca-4537-994d-e1ee3bb30f9c 33 fields · synced Jun 8, 2026