Catalog Number

-

Brand Name

Drive

Version/Model Number

AG-TITAN2020X16

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

INI

Product Code Name

VEHICLE, MOTORIZED 3-WHEELED

Public Device Record Key

a1c92d20-2a93-4e2f-aad8-b5076578d985

Public Version Date

July 01, 2019

Public Version Number

1

DI Record Publish Date

June 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-