Catalog Number

-

Brand Name

N/A

Version/Model Number

WQ8110-SNGL

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

c386baab-e47c-4cc5-8bf0-0054990c2a3a

Public Version Date

April 24, 2019

Public Version Number

3

DI Record Publish Date

October 13, 2016

Package DI Number

80092237618239

Quantity per Package

500

Contains DI Package

00092237618233

Package Discontinue Date

April 24, 2019

Package Status

Not in Commercial Distribution

Package Type

CA