Leica GLOW800

GUDID 07630003590401

Leica Microsystems (Schweiz) AG

Surgical microscope fluorescent angiography system
Primary Device ID07630003590401
NIH Device Record Key9afd9ef1-f8f3-4f45-8e3a-127e98e8f1a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeica GLOW800
Version Model Number000000000010448962
Company DUNS480198725
Company NameLeica Microsystems (Schweiz) 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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(847)8213462
Emailadam.blunier@leica-microsystem

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *
Handling Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 500 millibar and 1060 millibar
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107630003590401 [Primary]

FDA Product Code

IZISystem, x-ray, angiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-18
Device Publish Date2018-09-17

Devices Manufactured by Leica Microsystems (Schweiz) AG

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07630003561814 - M320 Optics Carrier2021-07-07 M320 Optics Carrier incl. Swing arm - for Leica surgical operating microscope systems: M320 FP12, M320 F12, M320 TP12, M320 LW12
07630003559095 - M320 W122021-07-01 W12 Wall Mount for M320 - for Leica surgical operating microscope system: M320 W12

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