Identity
- Trade Name
- HexaVue FDA UDI
- Generic Name
- Operating room audiovisual data/device management system application software FDA UDI
- Device Name
- The HexaVue Integration System with Surgical Light Control is a scalable and flexible OR Integration System that can be used in the operating room for the purpose of video routing, conferencing, streaming, recording and can accept SD, HD and 4K signals. FDA UDI
- Model / Reference
- HexaVue-SLC 1.0 FDA UDI
- Description
- The HexaVue Integration System with Surgical Light Control is a scalable and flexible OR Integration System that can be used in the operating room for the purpose of video routing, conferencing, streaming, recording and can accept SD, HD and 4K signals. FDA UDI
Identifiers
- Catalog Number
- XQHLC1 FDA UDI
- Primary DI / UDI-DI
- 00724995198497 FDA UDI
- FDA Product Code
- FTA FDA UDI
- GMDN Term
- Operating room audiovisual data/device management system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Operating room audiovisual data/device management system application software
HexaVue by Black Diamond Video, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- VISIUSmatrix — IMRIS Imaging, Inc. · Class I
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- Connected OR OS — Stryker Corp. · Class II
- INTELLIO LINK Dyonics Power II — Smith & Nephew, Inc. · Class I
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
- Black Diamond Video, Inc.
Sources (1)
- FDA UDI fc368ef3-de9e-4e04-a10f-b540253e255b 35 fields · synced Jun 6, 2026