Identity
- Trade Name
- JMA Optic Schütz FDA UDI
- Generic Name
- Facebow FDA UDI
- Device Name
- Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories FDA UDI
- Model / Reference
- 01570020 FDA UDI
- Description
- Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories FDA UDI
Identifiers
- Catalog Number
- NA FDA UDI
- Primary DI / UDI-DI
- B915015700201 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
JMA Optic Schütz 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 39976b83-30cd-45b4-b1a5-1e050d7dcaa8 37 fields · synced Jun 6, 2026