Catalog Number

989803173141

Brand Name

N/A

Version/Model Number

N/A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

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

-

Product Code

IKD

Product Code Name

CABLE, ELECTRODE

Public Device Record Key

8e059f7b-64b0-415b-ba17-ace8298f096b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 14, 2017

Package DI Number

57613327361921

Quantity per Package

20

Contains DI Package

07613327361926

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case