Catalog Number

-

Brand Name

Drive

Version/Model Number

8040-9

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

IMP

Product Code Name

CUSHION, WHEELCHAIR

Public Device Record Key

b6207169-a221-439a-ac5b-f9938444c8f3

Public Version Date

July 17, 2019

Public Version Number

4

DI Record Publish Date

May 19, 2017

Package DI Number

50822383517174

Quantity per Package

4

Contains DI Package

00822383517193

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-