Identity
- Trade Name
- Smart Correction FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Smart Correction Instruments Case 2 FDA UDI
- Model / Reference
- SC-INSTCASE2NS FDA UDI
- Description
- Smart Correction Instruments Case 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B562SCINSTCASE2NSE0 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wishbone Medical Inc.
Sources (1)
- FDA UDI e7bf4d82-57d5-4bfb-bd8b-65e2d3fdf42a 34 fields · synced May 31, 2026