Catalog Number

-

Brand Name

PURE ENRICHMENT

Version/Model Number

PEPULSE-RT

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

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

c7292b52-cbd4-47b1-a991-48f5efe6b68b

Public Version Date

August 01, 2022

Public Version Number

1

DI Record Publish Date

July 22, 2022

Package DI Number

B311PEPULSERT1

Quantity per Package

4

Contains DI Package

B311PEPULSERT0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER MASTER