Identity
- Trade Name
- Smart Correction FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Device Name
- Depth Gauge - 60mm - Non-Sterile FDA UDI
- Model / Reference
- 00-0014-60-WBNS FDA UDI
- Description
- Depth Gauge - 60mm - Non-Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- B56200001460WBNS0 FDA UDI
- FDA Product Code
- HTJ FDA UDI
- GMDN Term
- External orthopaedic fixation system, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4300 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
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 84e01c38-aac2-4a3a-b166-94777079fba2 34 fields · synced Jun 6, 2026