INFRARED 800 with FLOW® 800 Option

GUDID 04049539070128

Carl Zeiss Meditec AG

Surgical microscope fluorescent angiography system
Primary Device ID04049539070128
NIH Device Record Keyd68a746a-6dc9-4525-99e1-8a7f27d80e45
Commercial Distribution StatusIn Commercial Distribution
Brand NameINFRARED 800 with FLOW® 800 Option
Version Model Number7012
Company DUNS342228620
Company NameCarl Zeiss Meditec AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104049539070128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZISystem, X-Ray, Angiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-24

On-Brand Devices [INFRARED 800 with FLOW® 800 Option]

04049539102362302581-9245-000 302581-9250-000 302581-9246-000
040495390701287012

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