Catalog Number

-

Brand Name

Drive

Version/Model Number

8047-2018-2

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)

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

c545fa88-87fb-4ffe-9ead-9e8ca6d9545f

Public Version Date

July 17, 2019

Public Version Number

4

DI Record Publish Date

May 19, 2017

Package DI Number

50822383257056

Quantity per Package

7

Contains DI Package

00822383516233

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-