Catalog Number

-

Brand Name

N/A

Version/Model Number

WW6000

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

IKD

Product Code Name

Cable, Electrode

Public Device Record Key

b6310c87-2d7d-4903-bf7a-921df1eca0af

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 13, 2016

Package DI Number

80092237617461

Quantity per Package

500

Contains DI Package

00092237617465

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA