Catalog Number

-

Brand Name

BIS

Version/Model Number

186-0160

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K002734,K002734,K002734

Product Code

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Public Device Record Key

ba374457-a997-43ab-af63-09195020a028

Public Version Date

September 22, 2022

Public Version Number

10

DI Record Publish Date

September 07, 2017

Package DI Number

10884521657830

Quantity per Package

25

Contains DI Package

20884521657837

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK