DEFENDO Biopsy Valve Irrigator

GUDID 00677964060281

MEDIVATORS INC.

Endoscopic biopsy valve, sterile
Primary Device ID00677964060281
NIH Device Record Key789c919b-0a69-4ffc-a845-61e3f2250b0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEFENDO Biopsy Valve Irrigator
Version Model Number100303
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)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100677964060281 [Primary]
GS110677964060288 [Package]
Package: Carton [10 Units]
In Commercial Distribution
GS120677964060285 [Package]
Package: Case [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODCEndoscope Channel Accessory

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-15
Device Publish Date2016-09-21

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