Identity
- Trade Name
- INFRARED 800 with FLOW® 800 Option FDA UDI
- Generic Name
- Surgical microscope fluorescent angiography system FDA UDI
- Model / Reference
- 7012 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049539070128 FDA UDI
- FDA Product Code
- IZI FDA UDI
- GMDN Term
- Surgical microscope fluorescent angiography system 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
No
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
Yes
FDA UDI
Category: Surgical microscope fluorescent angiography system
INFRARED 800 with FLOW® 800 Option by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical microscope fluorescent angiography system.
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- Firefly — Intuitive Surgical, Inc. · Class II
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- 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
Cleared under the same submission
K100468 also covers:
K231075 also covers:
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
- Carl Zeiss Meditec AG
Sources (1)
- FDA UDI d68a746a-6dc9-4525-99e1-8a7f27d80e45 33 fields · synced May 30, 2026