DynaRide S 4 X-Lite Wheelchair 18"x16"-18 Flip Desk Arm ELR

GUDID 00616784027418

DYNAREX CORPORATION

Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
Primary Device ID00616784027418
NIH Device Record Key74f5ee62-dd3e-4583-8e51-89069edad596
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaRide S 4 X-Lite Wheelchair 18"x16"-18 Flip Desk Arm ELR
Version Model Number10274
Company DUNS008124539
Company NameDYNAREX CORPORATION
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 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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784027418 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IORWheelchair, Mechanical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-22
Device Publish Date2019-04-01

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