Urethrotomy obturator

GUDID 04059082010977

SOPRO-COMEG GmbH

Rigid endoscope obturator
Primary Device ID04059082010977
NIH Device Record Keya2ce08a0-b877-4651-a0ba-d93130490ef2
Commercial Distribution StatusIn Commercial Distribution
Brand NameUrethrotomy obturator
Version Model Number199 110 060BC
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
GS104059082010977 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZOUrethrotome

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082010977]

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

On-Brand Devices [Urethrotomy obturator]

04059082029863199 110 060
04059082010977199 110 060BC

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