Steel Button Folding Walker with 5 Wheels, Adults

GUDID 00840117336483

Weight Capacity 300lb, Not Sterile

DYNAREX CORPORATION

Handgrip disability-assistive walker, non-powered, foldable
Primary Device ID00840117336483
NIH Device Record Keyd5818268-618e-4c06-8136-9717c2e48ad6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteel Button Folding Walker with 5 Wheels, Adults
Version Model Number10170
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117336483 [Primary]
GS100840117336490 [Package]
Package: SH [4 Units]
In Commercial Distribution

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 Date2024-06-25
Device Publish Date2024-06-17

Devices Manufactured by DYNAREX CORPORATION

08401173315564 - DynaSafety Sheer Plastic Adhesive Bandages,Sterile with Non-Stick Pad2024-08-06 2" x 3"
08401173315700 - DynaSafety Sheer Plastic Adhesive Bandages,Sterile with Non-Stick Pad 2024-08-06 2" x 3"
08401173284570 - DynaCare Tampons Regular Cardboard Applicator 2024-08-02 Not-Sterile
00840117338067 - Resp-O2 M24 Oxygen E-Cylinder 4.6 L with CGA870 Toggle Valve 2024-08-02
00840117338074 - Resp-O2 M15 Oxygen Jumbo D-Cylinder 2.9 L with CGA870 Toggle Valve 2024-08-02
00840117338135 - Resp-O2 M15 Oxygen Standard D-Cylinder 2.89 L, With CGA 870 Post Valve 2024-08-02 Standard: Dot -3AL, Nominal Working Pressure; 139 (BAR), Hydraulic Test Pressure: 232 (BAR), Material: Aluminum alloy 6061, Actu
00840117334359 - Greenline Cruiser Wheelchair 16" with Foot Rest 2024-08-01
00840117334366 - Greenline Cruiser Wheelchair 18" with Foot Rest 2024-08-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.