Wheelchair Lap Hugger - DYNAREX CORPORATION

Duns Number:008124539

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More Product Details

Catalog Number

-

Brand Name

Wheelchair Lap Hugger

Version/Model Number

13030

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

KNO

Product Code Name

Accessories, Wheelchair

Device Record Status

Public Device Record Key

4c0dd508-551a-430e-84c3-e7c070f7db34

Public Version Date

February 25, 2021

Public Version Number

1

DI Record Publish Date

February 17, 2021

Additional Identifiers

Package DI Number

00616784303048

Quantity per Package

6

Contains DI Package

00616784303017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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