Catalog Number

-

Brand Name

Wheelchair Back Cushion Foam - 20 x 19

Version/Model Number

BKF-2019

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

2c525daa-1421-4bd1-9221-ddf6bd8190e1

Public Version Date

May 10, 2021

Public Version Number

3

DI Record Publish Date

November 11, 2020

Package DI Number

80092237604324

Quantity per Package

10

Contains DI Package

00092237604328

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton