Identity
- Trade Name
- BRACE BACK FDA UDI
- Generic Name
- Lumbar spine orthosis FDA UDI
- Device Name
- BRACE BACK, 1/EA FDA UDI
- Model / Reference
- SWT210 FDA UDI
- Description
- BRACE BACK, 1/EA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840216105270 FDA UDI
- FDA Product Code
- MRI FDA UDI
- GMDN Term
- Lumbar spine orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 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
Yes
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
Brace Back by Asp Global, LLC — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Asp Global, LLC
Sources (1)
- FDA UDI 7d69029c-7644-4fd0-82cf-77c2032dab85 34 fields · synced May 30, 2026