Catalog Number

ATAR D-IS1-2Pace

Brand Name

ATAR D-IS1 2Pace

Version/Model Number

ATAR D-IS1-2Pace

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 09, 2018

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

Yes

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

K070926

Product Code

IKD

Product Code Name

CABLE, ELECTRODE

Public Device Record Key

d10f5fa2-6f9e-46ec-b7fe-11d1cbfc5f50

Public Version Date

July 06, 2018

Public Version Number

5

DI Record Publish Date

October 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-