DynaGo Forearm Rollator

GUDID 00840117324442

DYNAREX CORPORATION

Handgrip disability-assistive walker, non-powered, foldable
Primary Device ID00840117324442
NIH Device Record Key917c40af-2e14-41ce-b504-516148680a34
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaGo Forearm Rollator
Version Model Number10214
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS100840117324442 [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 Date2022-10-25
Device Publish Date2022-10-17

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