Catalog Number

COV33111

Brand Name

NA

Version/Model Number

COV33111

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

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

8c1374e0-7a59-4a83-b7f2-cd1bd584823d

Public Version Date

August 14, 2019

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

20888551044513

Quantity per Package

10

Contains DI Package

10888551044516

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton