Working element

GUDID 04059082009964

SOPRO-COMEG GmbH

Endoscope assembly adaptor
Primary Device ID04059082009964
NIH Device Record Keyb82ccc3b-6dab-4bce-bd9b-0c9094d2da17
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorking element
Version Model Number196 010 010BC
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
GS104059082009964 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FAJCystoscope and accessories, flexible/rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082009964]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-22

On-Brand Devices [Working element]

04059082030524198 010 020
04059082030517198 010 010
04059082030449196 800 000
04059082030166196 010 020
04059082030159196 010 010
04059082010458198 010 020BC
04059082010441198 010 010BC
04059082010311196 800 000BC
04059082009995196 010 020BC
04059082009964196 010 010BC

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