Catalog Number

-

Brand Name

PURE ENRICHMENT

Version/Model Number

PETNEMPD2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

f86cbf58-7d84-44fa-baae-39dc2a7183eb

Public Version Date

August 22, 2022

Public Version Number

1

DI Record Publish Date

August 12, 2022

Package DI Number

B311PETNEMPD21

Quantity per Package

25

Contains DI Package

B311PETNEMPD2

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER CARTON