Cystoscopy sheath

GUDID 04059082010014

SOPRO-COMEG GmbH

Endoscope sheath, reusable
Primary Device ID04059082010014
NIH Device Record Keyba18d7a2-9cdd-454e-b317-1f9e2429d80f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCystoscopy sheath
Version Model Number196 020 200BC
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 Numberfalse
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
GS104059082010014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FAJCystoscope and accessories, flexible/rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082010014]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-03-11
Device Publish Date2016-12-22

On-Brand Devices [Cystoscopy sheath]

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04059082030562198 020 400
04059082030555198 020 300
04059082030548198 020 200
04059082030531198 020 100
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04059082030456196 800 100
04059082030432196 080 410
04059082030425196 080 400
04059082030418196 080 310
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04059082030227196 020 500
04059082030210196 020 400
04059082030203196 020 301
04059082030197196 020 300
04059082030180196 020 200
04059082030173196 020 100
04059082010502198 020 500BC
04059082010496198 020 400BC
04059082010489198 020 300BC
04059082010472198 020 200BC
04059082010465198 020 100BC
04059082010373196 810 101BC
04059082010328196 800 100BC
04059082010298196 080 410BC
04059082010281196 080 400BC
04059082010274196 080 310BC
04059082010267196 080 300BC
04059082010250196 080 210BC
04059082010243196 080 200BC
04059082010229196 080 100BC
04059082010205196 080 000BC
04059082010052196 020 500BC
04059082010045196 020 400BC
04059082010038196 020 301BC
04059082010021196 020 300BC
04059082010014196 020 200BC
04059082010007196 020 100BC

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