Identity
- Trade Name
- Smart Correction FDA UDI
- Generic Name
- External orthopaedic fixation system, reusable FDA UDI
- Device Name
- Rod Cutter - Non-Sterile FDA UDI
- Model / Reference
- 00-0038-60-WB FDA UDI
- Description
- Rod Cutter - Non-Sterile FDA UDI
Identifiers
- Catalog Number
- 00-0038-60-WB FDA UDI
- Primary DI / UDI-DI
- B56200003860WB0 FDA UDI
- FDA Product Code
- HXZ FDA UDI
- GMDN Term
- External orthopaedic fixation system, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Smart Correction by Wishbone Medical Inc. — 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
- Wishbone Medical Inc.
Sources (1)
- FDA UDI 57b33d8a-890f-4728-b573-2b5d60b094e0 36 fields · synced May 31, 2026