Catalog Number

-

Brand Name

McKesson

Version/Model Number

78668

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"

Yes

For Single-Use

Yes

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

08bff43c-6396-423c-a812-2b32743c332f

Public Version Date

March 16, 2020

Public Version Number

2

DI Record Publish Date

December 12, 2019

Package DI Number

20612479250509

Quantity per Package

5

Contains DI Package

10612479250496

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag