Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

TITAN1816X16

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 01, 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

INI

Product Code Name

VEHICLE, MOTORIZED 3-WHEELED

Public Device Record Key

2b544042-6293-4924-93f8-6ef686d3a792

Public Version Date

July 16, 2019

Public Version Number

3

DI Record Publish Date

July 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-