Catalog Number

-

Brand Name

NA

Version/Model Number

AE102

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

K061639

Product Code

GXZ

Product Code Name

ELECTRODE, NEEDLE

Public Device Record Key

3e63d9ce-57e7-4613-9b19-07a18a669118

Public Version Date

July 15, 2019

Public Version Number

1

DI Record Publish Date

July 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-