Urethrotomy sheath

GUDID 04059082010960

SOPRO-COMEG GmbH

Endoscope sheath, reusable
Primary Device ID04059082010960
NIH Device Record Key5b83c791-c863-48c7-96b7-ca174f2e807f
Commercial Distribution StatusIn Commercial Distribution
Brand NameUrethrotomy sheath
Version Model Number199 110 050BC
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
GS104059082010960 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZOUrethrotome

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082010960]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-03-11
Device Publish Date2016-09-12

On-Brand Devices [Urethrotomy sheath]

04059082029870199 110 080
04059082029856199 110 050
04059082029818195 810 102
04059082029757195 110 050
04059082010991199 110 080BC
04059082010960199 110 050BC
04059082009803195 810 102BC
04059082009285195 110 050BC

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