Catalog Number

-

Brand Name

N/A

Version/Model Number

WQ8110

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 24, 2019

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

eca07a86-6552-4e91-8e88-0135c9ca7255

Public Version Date

April 24, 2019

Public Version Number

3

DI Record Publish Date

October 13, 2016

Package DI Number

80092237617386

Quantity per Package

500

Contains DI Package

00092237617380

Package Discontinue Date

April 24, 2019

Package Status

Not in Commercial Distribution

Package Type

CA