Catalog Number

-

Brand Name

N/A

Version/Model Number

8227132

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

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

K850107,K850107

Product Code

GXZ

Product Code Name

ELECTRODE, NEEDLE

Public Device Record Key

8be1e475-0aae-4824-bb25-90e600d5af21

Public Version Date

March 04, 2021

Public Version Number

2

DI Record Publish Date

April 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-