Identity
- Trade Name
- Dynamic Femur Fracture Brace FDA UDI
- Generic Name
- Multiple-joint lower limb orthosis FDA UDI
- Device Name
- XL DF2 Femur Fracture Brace, Right, Static Knee FDA UDI
- Model / Reference
- NS-DF2B-0105 FDA UDI
- Description
- XL DF2 Femur Fracture Brace, Right, Static Knee FDA UDI
Identifiers
- Catalog Number
- NS-DF2B-0105 FDA UDI
- Primary DI / UDI-DI
- 00840194462907 FDA UDI
- FDA Product Code
- IQI FDA UDI
- GMDN Term
- Multiple-joint lower limb orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dynamic Femur Fracture Brace by Orthopediatrics Corp. — 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
- Orthopediatrics Corp.
Sources (1)
- FDA UDI 5be1d415-b05a-41b0-b0be-0a9a1a192341 35 fields · synced Jun 8, 2026