Catalog Number

60-201-00

Brand Name

Covered Cushions and Wedges

Version/Model Number

60-201-00

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

Yes

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

CCX

Product Code Name

Support, Patient Position

Public Device Record Key

8c9482db-4519-460d-bd9b-10f6ecceb254

Public Version Date

August 06, 2020

Public Version Number

1

DI Record Publish Date

July 29, 2020

Package DI Number

00810044961478

Quantity per Package

6

Contains DI Package

10810044961475

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case