Identity
- Trade Name
- LUNA FDA UDI
- Generic Name
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- LUNA Fluorescence Angiography System with SPY-QCM FDA UDI
- Model / Reference
- LU3000 FDA UDI
- Description
- LUNA Fluorescence Angiography System with SPY-QCM FDA UDI
Identifiers
- Catalog Number
- LU3000 FDA UDI
- Primary DI / UDI-DI
- 00858701006032 FDA UDI
- FDA Product Code
- IZI FDA UDI
- GMDN Term
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1600 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
No
FDA UDI
Category: Stationary general-purpose fluoroscopic x-ray system, digital
Luna by Novadaq Technologies 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
- Novadaq Technologies Inc
Sources (1)
- FDA UDI f148dc77-462c-4aa4-9cf0-69fc9f2af2d6 35 fields · synced Jun 8, 2026