Catalog Number

-

Brand Name

Drive

Version/Model Number

8084-MED

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 21, 2019

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)

Yes

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

9f17f80e-120e-42b4-8cf0-81749ff7a334

Public Version Date

June 02, 2020

Public Version Number

5

DI Record Publish Date

July 10, 2017

Package DI Number

00822383520780

Quantity per Package

2

Contains DI Package

00122383520781

Package Discontinue Date

June 21, 2019

Package Status

Not in Commercial Distribution

Package Type

-