Urethrotomy knife

GUDID 04059082029825

SOPRO-COMEG GmbH

Urethrotome
Primary Device ID04059082029825
NIH Device Record Keyb83cf454-ad9f-48b1-86f4-abbe816a61ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameUrethrotomy knife
Version Model Number195 810 121
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 Numbertrue
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
GS104059082029825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZOUrethrotome

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082029825]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-20

On-Brand Devices [Urethrotomy knife]

04059082031095195 400 110
04059082029900397 500 038
04059082029894397 500 037
04059082029849195 810 123
04059082029832195 810 122
04059082029825195 810 121
04059082029801195 120 020
04059082029795195 120 001
04059082027333397 500 038BC
04059082027326397 500 037BC
04059082009889195 810 123BC
04059082009872195 810 122BC
04059082009865195 810 121BC
04059082009582195 400 110 C
04059082009346195 120 020BC
04059082009339195 120 001BC

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