Stand Up Cane - Stand Up Cane, Black - DYNAREX CORPORATION

Duns Number:008124539

Device Description: Stand Up Cane, Black

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More Product Details

Catalog Number

-

Brand Name

Stand Up Cane

Version/Model Number

10139

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

INP

Product Code Name

Tips And Pads, Cane, Crutch And Walker

Device Record Status

Public Device Record Key

453bd3ac-0670-4c46-938d-5c42ad2915f3

Public Version Date

September 09, 2021

Public Version Number

1

DI Record Publish Date

September 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DYNAREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 694
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 2