DynaGo Euro Rollator

GUDID 00616784020716

DYNAREX CORPORATION

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Primary Device ID00616784020716
NIH Device Record Key35bc5b40-3af3-48b2-a742-12ab3f523ce1
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaGo Euro Rollator
Version Model Number10207
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100616784020716 [Primary]

FDA Product Code

ITJWalker, Mechanical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-21
Device Publish Date2019-11-13

On-Brand Devices [DynaGo Euro Rollator]

0061678402071610207
0084011732405310207

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