LEICA FL800

GUDID 07630003575248

Leica Microsystems (Schweiz) AG

Surgical microscope fluorescent angiography system
Primary Device ID07630003575248
NIH Device Record Key360d39b8-f41c-48f5-883a-75308ef28e66
Commercial Distribution StatusIn Commercial Distribution
Brand NameLEICA FL800
Version Model Number000000000010448715
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)4055413
Emailadam.blunier@leica-microsystem

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107630003575248 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2016-09-08

On-Brand Devices [LEICA FL800]


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