Identity
- Trade Name
- CODMAN SOFWIRE FDA UDI
- Generic Name
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile FDA UDI
- Device Name
- CODMAN SOFWIRE SS Single Cable with Leader, 1 Cinch, 1 Tightener FDA UDI
- Model / Reference
- 46-4019 FDA UDI
- Description
- CODMAN SOFWIRE SS Single Cable with Leader, 1 Cinch, 1 Tightener FDA UDI
Identifiers
- Catalog Number
- 464019 FDA UDI
- Primary DI / UDI-DI
- 10705034002262 FDA UDI
- FDA Product Code
- JDQ FDA UDI
- GMDN Term
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3010 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Codman Sofwire by Cerenovus, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Cerenovus, Inc.
Sources (1)
- FDA UDI 00fe798f-bd57-4536-acac-9ed23048f9d3 37 fields · synced Jun 1, 2026