Catalog Number

-

Brand Name

Ever-Soft Positioning Wedge

Version/Model Number

13001

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

f88d7f84-5897-4f71-9b0d-82ec3d52a2c6

Public Version Date

April 30, 2021

Public Version Number

1

DI Record Publish Date

April 22, 2021

Package DI Number

00616784300146

Quantity per Package

2

Contains DI Package

00840117307728

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper