Identity
- Trade Name
- Viseon Image Control Box FDA UDI
- Generic Name
- Spinal endoscopic-access system FDA UDI
- Device Name
- Image Control Box - For use with the MaxView™ System devices. FDA UDI
- Model / Reference
- ICB-02 FDA UDI
- Description
- Image Control Box - For use with the MaxView™ System devices. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850007069254 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Spinal endoscopic-access system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Spinal endoscopic-access system
Viseon Image Control Box by Viseon, 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
- Viseon, Inc.
Sources (1)
- FDA UDI 26237767-8bd5-4af4-95b3-8e067a2569a7 34 fields · synced May 30, 2026