Catalog Number

-

Brand Name

Moore Medical

Version/Model Number

78667

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

K132998,K132998,K132998,K132998

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

7de70198-09b3-4554-98da-3e5f206d7943

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

December 09, 2016

Package DI Number

20607415001352

Quantity per Package

25

Contains DI Package

10607415002130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box