Cystoscopy instrument

GUDID 04059082026176

SOPRO-COMEG GmbH

Rigid endoscopic grasping forceps, reusable
Primary Device ID04059082026176
NIH Device Record Key28c8df46-52b8-4ba2-b60a-6bacff87c5be
Commercial Distribution StatusIn Commercial Distribution
Brand NameCystoscopy instrument
Version Model Number395 400 113
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
GS104059082026176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FAJCystoscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082026176]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-20

On-Brand Devices [Cystoscopy instrument]

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04059082026183395 400 114
04059082026176395 400 113
04059082026152395 400 107
04059082026145395 400 106
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04059082026008395 400 035BC
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04059082025698395 400 000
04059082012858390 700 410
04059082012841390 700 400

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