Catalog Number

-

Brand Name

PURE ENRICHMENT

Version/Model Number

PETNEMPD5

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

f8380497-a182-47ca-8667-951a29e9a4ed

Public Version Date

August 22, 2022

Public Version Number

1

DI Record Publish Date

August 12, 2022

Package DI Number

B311PETNEMPD51

Quantity per Package

10

Contains DI Package

B311PETNEMPD5

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER CARTON