Catalog Number

-

Brand Name

Ever-Soft Lumbar Cushions

Version/Model Number

13042

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)

-

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

b3f74b7a-f45c-4bc6-85d2-dd7a4431bca8

Public Version Date

March 14, 2022

Public Version Number

1

DI Record Publish Date

March 06, 2022

Package DI Number

00840117321885

Quantity per Package

4

Contains DI Package

00840117321892

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Shipper