Identity
- Trade Name
- Push braces FDA UDI
- Generic Name
- Lumbar spine orthosis FDA UDI
- Device Name
- Push care Back Brace 2 FDA UDI
- Model / Reference
- 1.40.1.02 FDA UDI
- Description
- Push care Back Brace 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08715669003652 FDA UDI
- FDA Product Code
- IQE 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Lumbar spine orthosis
Push braces by Nea International B.V. — 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
- Nea International B.V.
Sources (1)
- FDA UDI b44d5028-cbe3-4e85-8af5-70ecc3e0ec31 34 fields · synced Jun 8, 2026