Catalog Number

-

Brand Name

PURE ENRICHMENT

Version/Model Number

PEPADBFLY

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

042ceed0-5bf6-4206-b932-1ecb0644fc34

Public Version Date

March 02, 2022

Public Version Number

6

DI Record Publish Date

October 19, 2016

Package DI Number

B311PEPADBFLY1

Quantity per Package

350

Contains DI Package

B311PEPADBFLY0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON