Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

AGF-101

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Public Device Record Key

1b4587c6-fa11-49ac-9632-420daa8a5651

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

July 01, 2016

Package DI Number

10822383104284

Quantity per Package

400

Contains DI Package

50822383104282

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-