Identity
- Trade Name
- SICAT JMA blue FDA UDI
- Generic Name
- Facebow FDA UDI
- Device Name
- Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements. FDA UDI
- Model / Reference
- 01170030 FDA UDI
- Description
- Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements. FDA UDI
Identifiers
- Catalog Number
- NA FDA UDI
- Primary DI / UDI-DI
- B915011700300 FDA UDI
- FDA Product Code
- NFS FDA UDI
- GMDN Term
- Facebow FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.2060 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
SICAT JMA blue by zebris MEDICAL GmbH — 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
- zebris MEDICAL GmbH
Sources (1)
- FDA UDI 0ccd1ab0-fe3d-4956-8474-fca5aa2737ef 37 fields · synced May 31, 2026