Identity
- Trade Name
- Quest Spectrum Kit for open surgery FDA UDI
- Generic Name
- Surgical microscope fluorescent angiography system FDA UDI
- Device Name
- kit for open surgery: 1x indocyanine Green for injection, USP 25mg vial 1x sterile water for injection, USP 10ml vial 1x1 piece drape art-drp-0-004 FDA UDI
- Model / Reference
- ART-ICG-0001 FDA UDI
- Description
- kit for open surgery: 1x indocyanine Green for injection, USP 25mg vial 1x sterile water for injection, USP 10ml vial 1x1 piece drape art-drp-0-004 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719324487030 FDA UDI
- FDA Product Code
- OWN FDA UDI
- GMDN Term
- Surgical microscope fluorescent angiography system 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical microscope fluorescent angiography system
Quest Spectrum Kit for open surgery by Quest Projects B.V. — 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
- Quest Projects B.V.
Sources (1)
- FDA UDI 4f81fe34-4e75-44b5-ab22-e91de2f4b33c 33 fields · synced Jun 1, 2026