Nephroscopy sheath

GUDID 04059082009643

SOPRO-COMEG GmbH

Endoscope sheath, reusable
Primary Device ID04059082009643
NIH Device Record Key4849e6f5-4584-48ce-980c-b3d173081f23
Commercial Distribution StatusIn Commercial Distribution
Brand NameNephroscopy sheath
Version Model Number195 800 035BC
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
GS104059082009643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FAJCystoscope and accessories, flexible/rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082009643]

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 [Nephroscopy sheath]

04059082030128195 800 035
04059082030111195 800 030
04059082030098195 800 010
04059082009643195 800 035BC
04059082009636195 800 030BC
04059082009605195 800 010BC

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