Cystoscope

GUDID 04059082030036

SOPRO-COMEG GmbH

Rigid cystoscope
Primary Device ID04059082030036
NIH Device Record Key45619dc7-43b6-499a-8537-2ede2a58a8ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameCystoscope
Version Model Number165 403 002
Company DUNS507185952
Company NameSOPRO-COMEG GmbH
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 Batchtrue
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
GS104059082030036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FAJCystoscope and accessories, flexible/rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082030036]

Moist Heat or Steam Sterilization


[04059082030036]

Moist Heat or Steam Sterilization


[04059082030036]

Moist Heat or Steam Sterilization


[04059082030036]

Moist Heat or Steam Sterilization


[04059082030036]

Moist Heat or Steam Sterilization


[04059082030036]

Moist Heat or Steam Sterilization


[04059082030036]

Moist Heat or Steam Sterilization


[04059082030036]

Moist Heat or Steam Sterilization


[04059082030036]

Moist Heat or Steam Sterilization


[04059082030036]

Moist Heat or Steam Sterilization


[04059082030036]

Moist Heat or Steam Sterilization


[04059082030036]

Moist Heat or Steam Sterilization


[04059082030036]

Moist Heat or Steam Sterilization


[04059082030036]

Moist Heat or Steam Sterilization


[04059082030036]

Moist Heat or Steam Sterilization


[04059082030036]

Moist Heat or Steam Sterilization


[04059082030036]

Moist Heat or Steam Sterilization


[04059082030036]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-20

On-Brand Devices [Cystoscope]

04059082030043165 403 005
04059082030036165 403 002
04059082030029165 403 001
04059082030012165 403 000
04059082030005165 303 002
04059082029993165 303 001
04059082029986165 293 002
04059082029979165 293 001
04059082029962165 293 000
04059082029955165 271 875
04059082029948165 271 872
04059082029931165 271 870
04059082029924165 211 870
04059082029917161 271 140
04059082004211165 403 005BC001
04059082004198165 403 002BC001
04059082004174165 403 001BC001
04059082004150165 403 000BC001
04059082004143165 303 002BC001
04059082004136165 303 001BC001
04059082004112165 293 002BC001
04059082004105165 293 001BC001
04059082004082165 293 000BC001
04059082004068165 271 875BC001
04059082004044165 271 872BC001
04059082004020165 271 870BC001
04059082003993165 211 870BC001
04059082002774161 271 140BC001

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