Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

SF1320-BL

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

K051473

Product Code

INI

Product Code Name

VEHICLE, MOTORIZED 3-WHEELED

Public Device Record Key

65c2f2de-5243-491f-b513-b0f6c8f45af2

Public Version Date

July 16, 2019

Public Version Number

2

DI Record Publish Date

November 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-