Identity
- Trade Name
- Smart Correction FDA UDI
- Generic Name
- Manual orthopaedic bender, reusable FDA UDI
- Device Name
- Ø5.5 Rod Bender, French FDA UDI
- Model / Reference
- 09.0663 FDA UDI
- Description
- Ø5.5 Rod Bender, French FDA UDI
Identifiers
- Catalog Number
- 09.0663 FDA UDI
- Primary DI / UDI-DI
- B5620906630 FDA UDI
- FDA Product Code
- HXW FDA UDI
- GMDN Term
- Manual orthopaedic bender, 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
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
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 493be2c6-8e78-4813-ab21-d40389f449ba 36 fields · synced Jun 8, 2026