Catalog Number

PRO-100

Brand Name

PlayMakar

Version/Model Number

PRO-100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

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

K121353,K121353

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

b4e1d8ae-6a25-433d-bb09-5597a0b63bd2

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

February 22, 2019

Package DI Number

10856675008011

Quantity per Package

160

Contains DI Package

00856675008014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton