Accessory for urology

GUDID 04059082026527

SOPRO-COMEG GmbH

Urethral bougie, reusable
Primary Device ID04059082026527
NIH Device Record Key03cd4906-34f4-42ab-b388-57915f46d632
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccessory for urology
Version Model Number395 410 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
GS104059082026527 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FAJCystoscope and accessories, flexible/rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082026527]

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 [Accessory for urology]

04059082030890395 410 018
04059082030883395 410 017
04059082030876395 410 016
04059082030869395 410 015
04059082030852395 410 014
04059082030845395 410 013
04059082030838395 410 012
04059082030821395 410 011
04059082030814395 410 010
04059082030807395 410 009
04059082030791395 410 008
04059082030784395 410 007
04059082030777395 410 005
04059082030760395 410 004
04059082030753395 410 003
04059082030746395 410 002
04059082030739395 410 001
04059082026602395 410 018BC
04059082026596395 410 017BC
04059082026589395 410 016BC
04059082026572395 410 015BC
04059082026565395 410 014BC
04059082026558395 410 013BC
04059082026541395 410 012BC
04059082026534395 410 011BC
04059082026527395 410 010BC
04059082026510395 410 009BC
04059082026503395 410 008BC
04059082026497395 410 007BC
04059082026473395 410 005BC
04059082026466395 410 004BC
04059082026459395 410 003BC
04059082026442395 410 002BC
04059082026435395 410 001BC

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