Identity
- Trade Name
- Firefly FDA UDI
- Generic Name
- Surgical microscope fluorescent angiography system FDA UDI
- Device Name
- FLUORESCENCE IMAGING PROCEDURE KIT FDA UDI
- Model / Reference
- 950156 FDA UDI
- Description
- FLUORESCENCE IMAGING PROCEDURE KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00886874112779 FDA UDI
- FDA Product Code
- NAY 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
No
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
Yes
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
No
FDA UDI
Category: Surgical microscope fluorescent angiography system
Firefly by Intuitive Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical microscope fluorescent angiography system.
- Quest Spectrum Kit for open surgery — Quest Projects B.V. · Class II
- Surgical Microscope MM90/YOH — MITAKA KOHKI CO., LTD. · Class I
- INFRARED 800 with FLOW® 800 Option — Carl Zeiss Meditec AG · Class II
- Modus IR — Synaptive Medical Inc · Class II
- PDE-GEN3 — Hamamatsu Photonics K.K. · Class II
- AEOS — AESCULAP, INC. · Class II
- LEICA FL800 — Leica Microsystems (Schweiz) AG · Class II
- pde-neo — Hamamatsu Photonics K.K. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Intuitive Surgical, Inc.
Sources (1)
- FDA UDI 9fa664b2-4aff-41db-afe2-15ccb77d4a09 33 fields · synced Jun 9, 2026