Identity
- Trade Name
- Push braces FDA UDI
- Generic Name
- Wrist orthosis FDA UDI
- Device Name
- Push care Wrist Brace R3 FDA UDI
- Model / Reference
- 1.10.1.23 FDA UDI
- Description
- Push care Wrist Brace R3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08715669003027 FDA UDI
- FDA Product Code
- IQI FDA UDI
- GMDN Term
- Wrist 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Wrist orthosis
Push braces by Nea International B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wrist orthosis.
- Wrist Lacer — MEDICAL SPECIALTIES INCORPORATED · Class I
- CMC Thumb Support — MEDICAL SPECIALTIES INCORPORATED · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
- PROCARE — DJO, LLC · Class I
- Wrist Lacer — MEDICAL SPECIALTIES INCORPORATED · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
- Carpal Pads With Pres. Sens. — SILIPOS Holding LLC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nea International B.V.
Sources (1)
- FDA UDI 7f097d9d-aa69-4fad-b8ce-2e77c0639396 34 fields · synced May 30, 2026