Identity
- Trade Name
- Grand Pre Plate Screw Depth Guide FDA UDI
- Generic Name
- Orthopaedic fixation implant alignment tool FDA UDI
- Model / Reference
- 201.035.00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851599007372 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic fixation implant alignment tool FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Grand Pre Plate Screw Depth Guide by Jace Medical, Llc — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jace Medical, Llc
Sources (1)
- FDA UDI 6c15a3a4-6cc0-4d57-a2f9-0ffdd9b805ee 33 fields · synced Jun 1, 2026