Catalog Number

561616

Brand Name

Action®

Version/Model Number

Adaptive Pad

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

KIC

Product Code Name

Cushion, Flotation

Public Device Record Key

ccdd765f-7182-4b50-875e-5ace17bb7346

Public Version Date

October 15, 2021

Public Version Number

1

DI Record Publish Date

October 07, 2021

Package DI Number

00089904011053

Quantity per Package

25

Contains DI Package

00089904011046

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case