Catalog Number

-

Brand Name

BIS

Version/Model Number

186-0212

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K062692,K062692,K062692,K062692

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

5de3792a-8258-4ee0-a0e0-b7d7a716758b

Public Version Date

October 14, 2022

Public Version Number

10

DI Record Publish Date

September 25, 2016

Package DI Number

90884521657850

Quantity per Package

9999

Contains DI Package

20884521134475

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PALLET