Resectoscopy sheath

GUDID 04059082008554

SOPRO-COMEG GmbH

Endoscope sheath, reusable
Primary Device ID04059082008554
NIH Device Record Keyc8f9ee3f-5e9a-443c-834b-5359360cacc0
Commercial Distribution StatusIn Commercial Distribution
Brand NameResectoscopy sheath
Version Model Number195 040 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
GS104059082008554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDCRESECTOSCOPE, WORKING ELEMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082008554]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-03-11
Device Publish Date2016-09-12

On-Brand Devices [Resectoscopy sheath]

04059082031842199 530 500
04059082031811199 075 020
04059082031750199 040 540
04059082031743199 040 530
04059082031736199 040 516
04059082031729199 040 515
04059082031712199 040 514
04059082031705199 040 510
04059082031699199 040 010
04059082031682199 030 540
04059082031675199 030 514
04059082031668199 020 514
04059082031613195 810 101
04059082031583195 800 100
04059082031552195 400 010
04059082031514195 200 250
04059082031415195 040 540
04059082031408195 040 530
04059082031392195 040 525
04059082031385195 040 523
04059082031378195 040 518
04059082031361195 040 514
04059082031354195 040 025
04059082031347195 040 010
04059082031330195 030 521
04059082031323195 030 514
04059082031316195 030 501
04059082031309195 020 514
04059082025452395 015 027
04059082025445395 015 025
04059082025438395 015 020
04059082011028199 530 500BC
04059082010878199 075 020BC
04059082010809199 040 540BC
04059082010793199 040 530BC
04059082010779199 040 516BC
04059082010762199 040 515BC
04059082010755199 040 514BC
04059082010748199 040 510BC
04059082010731199 040 010BC
04059082010717199 030 540BC
04059082010700199 030 514BC
04059082010694199 020 514BC
04059082009797195 810 101BC
04059082009704195 800 100BC
04059082009520195 400 010BC
04059082009476195 200 250BC
04059082008783195 040 540BC
04059082008776195 040 530BC
04059082008752195 040 525BC

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