Catalog Number

-

Brand Name

Drive

Version/Model Number

LK3JELR

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"

-

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

IOR

Product Code Name

Wheelchair, mechanical

Public Device Record Key

58f03a28-4f7b-4573-bc20-ab39f9fea5f3

Public Version Date

June 02, 2020

Public Version Number

2

DI Record Publish Date

June 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-