Identity
- Trade Name
- First Choice® DRUJ System FDA UDI
- Generic Name
- Custom-made orthopaedic/craniofacial surgical guide FDA UDI
- Device Name
- Integra® First Choice® DRUJ System DRUJ Osteotomy Guide The DRUJ (distal radioulnar joint) Osteotomy Guide attaches onto reamers and is used to determine a standard, medium, or long resection for partial resurfacing implants. FDA UDI
- Model / Reference
- OSG610001 FDA UDI
- Description
- Integra® First Choice® DRUJ System DRUJ Osteotomy Guide The DRUJ (distal radioulnar joint) Osteotomy Guide attaches onto reamers and is used to determine a standard, medium, or long resection for partial resurfacing implants. FDA UDI
Identifiers
- Catalog Number
- OSG-610-001 FDA UDI
- Primary DI / UDI-DI
- 10381780246503 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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
Moist Heat or Steam Sterilization FDA UDI
Category: Custom-made orthopaedic/craniofacial surgical guide
First Choice® DRUJ System by Ascension Orthopedics, Inc. — 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
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI 105d3e51-1069-4106-b0ac-6de1daaf1916 37 fields · synced May 30, 2026