Identity
- Trade Name
- Harmony iQ FDA UDI
- Generic Name
- Operating room audiovisual data/device management system application software FDA UDI
- Device Name
- The Surgical Light Control and Surgical Camera Control for the Harmony IQ 3600 Integration Systems promotes efficient and prompt reaction to procedure events. FDA UDI
- Model / Reference
- Harmony iQ 3600 FDA UDI
- Description
- The Surgical Light Control and Surgical Camera Control for the Harmony IQ 3600 Integration Systems promotes efficient and prompt reaction to procedure events. FDA UDI
Identifiers
- Catalog Number
- RLQ3600SLC FDA UDI
- Primary DI / UDI-DI
- 00724995199142 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
- 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
No
FDA UDI
Over-the-Counter
Yes
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
Harmony iQ by Black Diamond Video, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Black Diamond Video, Inc.
Sources (1)
- FDA UDI d618ba15-ec49-4ab8-8187-ba34ee6252e8 36 fields · synced Jun 1, 2026