Catalog Number

D84XX

Brand Name

NA

Version/Model Number

D84XX

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 24, 2022

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)

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

f9fac032-940b-4341-8370-93cdc83441d0

Public Version Date

June 09, 2022

Public Version Number

2

DI Record Publish Date

September 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-