Identity
- Trade Name
- Template FDA UDI
- Generic Name
- Custom-made orthopaedic/craniofacial surgical guide FDA UDI
- Device Name
- Patient specific, 3D printed, single use surgical marking template based a patient’s baseline status and treatment plan. RX only, non-diagnostic. FDA UDI
- Model / Reference
- MOST FDA UDI
- Description
- Patient specific, 3D printed, single use surgical marking template based a patient’s baseline status and treatment plan. RX only, non-diagnostic. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00196852129638 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Template by Mirrorme3D, LLC — 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
- Mirrorme3D, LLC
Sources (1)
- FDA UDI 737895ec-c482-41de-81c9-238bb649bc3b 34 fields · synced May 30, 2026