Catalog Number

-

Brand Name

Bariatric Gel/Foam Cushion 26"x20"x3"

Version/Model Number

13052

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

IMP

Product Code Name

Cushion, Wheelchair

Public Device Record Key

fc041d50-e2c0-467f-bc0e-9fe6a3df9c8a

Public Version Date

July 19, 2022

Public Version Number

2

DI Record Publish Date

April 22, 2021

Package DI Number

00840117321144

Quantity per Package

5

Contains DI Package

00840117321113

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper