Identity
- Trade Name
- OWANDY FDA UDI
- Generic Name
- Diagnostic-imaging multiformat camera FDA UDI
- Device Name
- This is an extra- and intra-oral Sopro 617 camera designed for dental applications. It allows the user to see anatomical and pathological details that cannot be seen with the naked eye, as well as pathology control and post-treatment. FDA UDI
- Model / Reference
- OWANDY-CAM HD NTSC FDA UDI
- Description
- This is an extra- and intra-oral Sopro 617 camera designed for dental applications. It allows the user to see anatomical and pathological details that cannot be seen with the naked eye, as well as pathology control and post-treatment. FDA UDI
Identifiers
- Catalog Number
- S_OCAM_0002 FDA UDI
- Primary DI / UDI-DI
- 03760278264913 FDA UDI
- FDA Product Code
- NYH FDA UDI
- GMDN Term
- Diagnostic-imaging multiformat camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1740 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Diagnostic-imaging multiformat camera
Owandy by Sopro — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Sopro
Sources (1)
- FDA UDI 00b774e1-7d84-421e-a8eb-e630dc30566c 35 fields · synced May 30, 2026