Catalog Number

-

Brand Name

PURE ENRICHMENT

Version/Model Number

PEPEAK

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

ISA

Product Code Name

Massager, Therapeutic, Electric

Public Device Record Key

2821efff-1603-4498-ba65-01469eb497e8

Public Version Date

August 20, 2020

Public Version Number

2

DI Record Publish Date

November 15, 2019

Package DI Number

B311PEPEAK1

Quantity per Package

40

Contains DI Package

B311PEPEAK0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON