DEFENDO Disposable Biopsy Valve

GUDID 00677964065064

MEDIVATORS INC.

Endoscopic biopsy valve, sterile
Primary Device ID00677964065064
NIH Device Record Keyc5d6abc1-274f-47ba-8f00-fb4f0b770b07
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEFENDO Disposable Biopsy Valve
Version Model Number100319
Company DUNS068199363
Company NameMEDIVATORS INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100677964065064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDFColonoscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-21

On-Brand Devices [DEFENDO Disposable Biopsy Valve]

00677964065064100319
00677964065057100318
00677964060267100302
00677964060212100301

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