Catalog Number

-

Brand Name

Philips PulseRelief

Version/Model Number

PR3841

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2017

Issuing Agency

In GS1

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)

Yes

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

0714cca4-8a38-466f-b35a-53af5ab60fb0

Public Version Date

July 07, 2021

Public Version Number

8

DI Record Publish Date

August 24, 2016

Package DI Number

20075020050858

Quantity per Package

6

Contains DI Package

00007502005175

Package Discontinue Date

September 26, 2018

Package Status

Not in Commercial Distribution

Package Type

-