Steerable Knee Walker with Basket - DYNAREX CORPORATION

Duns Number:008124539

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More Product Details

Catalog Number

-

Brand Name

Steerable Knee Walker with Basket

Version/Model Number

10216

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

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

ITJ

Product Code Name

Walker, Mechanical

Device Record Status

Public Device Record Key

35279f16-7a98-465a-93cd-b9c2c61b9777

Public Version Date

October 21, 2020

Public Version Number

2

DI Record Publish Date

October 08, 2019

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