Identity
- Trade Name
- ZEOS FDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- ZEOS 4K HDR, CAMERA CONTROL UNIT FDA UDI
- Model / Reference
- 84-10-5001 FDA UDI
- Description
- ZEOS 4K HDR, CAMERA CONTROL UNIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812231033975 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Endoscopic video image processing unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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: Endoscopic video image processing unit
Zeos by Santa Barbara Imaging Systems, Inc. — 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
- Santa Barbara Imaging Systems, Inc.
Sources (1)
- FDA UDI e3d5c6e0-0929-42b3-821d-b8128f146f09 34 fields · synced May 30, 2026