Urethrotome

GUDID 04059082025643

SOPRO-COMEG GmbH

Urethrotome
Primary Device ID04059082025643
NIH Device Record Key27a3faf9-3bce-461e-af82-b63f926e54d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameUrethrotome
Version Model Number395 160 000
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
GS104059082025643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZOUrethrotome

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082025643]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-12

Devices Manufactured by SOPRO-COMEG GmbH

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04059082003757 - Hysteroscope2019-11-08
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04059082003795 - Hysteroscope2019-11-08
04059082003818 - Hysteroscope2019-11-08
04059082003856 - Hysteroscope2019-11-08
04059082003870 - Hysteroscope2019-11-08
04059082003894 - Hysteroscope2019-11-08

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