Catalog Number

-

Brand Name

Drive

Version/Model Number

8046-1

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

fe43e986-3985-4812-85d4-0c40d18d22a5

Public Version Date

July 17, 2019

Public Version Number

5

DI Record Publish Date

May 19, 2017

Package DI Number

50822383517198

Quantity per Package

4

Contains DI Package

00822383514390

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-