Identity
- Trade Name
- SurgiCase OOS FDA UDI
- Generic Name
- CAD/CAM software FDA UDI
- Device Name
- SurgiCase OOS FDA UDI
- Model / Reference
- SurgiCase OOS FDA UDI
- Description
- SurgiCase OOS FDA UDI
Identifiers
- Catalog Number
- SurgiCase OOS FDA UDI
- Primary DI / UDI-DI
- E314SURGICASEOOS0 FDA UDI
- FDA Product Code
- OUG FDA UDI
- GMDN Term
- CAD/CAM software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Category: CAD/CAM software
SurgiCase OOS by Materialise NV — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CAD/CAM software.
- CEREC — Sirona Dental Systems GmbH · Class II
- DTX Studio™ Lab — Nobel Biocare AG · Class II
- CAD/CAM Software — Sirona Dental Systems GmbH · Class II
- CEREC Guide — Sirona Dental Systems GmbH · Class I
- CEREC Guide — Sirona Dental Systems GmbH · Class I
- CEREC Guide — Sirona Dental Systems GmbH · Class I
- CAD/CAM Software — Sirona Dental Systems GmbH · Class II
- CEREC Guide — Sirona Dental Systems GmbH · Class I
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
- Materialise NV
Sources (1)
- FDA UDI cafd4c80-0a9e-4e74-9414-8555130d8be8 34 fields · synced May 30, 2026