DEFENDO SINGLE USE VALVE KIT

GUDID 00677964092992

MEDIVATORS INC.

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Primary Device ID00677964092992
NIH Device Record Key3dab36fc-89bb-43be-b017-98744ebce33e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEFENDO SINGLE USE VALVE KIT
Version Model Number100322
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 Kittrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100677964092992 [Primary]
GS140677964009998 [Package]
Package: [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDFColonoscope And Accessories, Flexible/Rigid
MNLAccessories, Cleaning Brushes, For Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-23
Device Publish Date2019-06-04

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