Catalog Number

-

Brand Name

PlayMakar

Version/Model Number

PRO-22

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

K082065,K082065

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

b1c5dcae-4c59-47dc-97b6-8a16f37f07aa

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

February 22, 2019

Package DI Number

10856675008257

Quantity per Package

100

Contains DI Package

00856675008250

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton