Catalog Number

-

Brand Name

POWER PLAY

Version/Model Number

PPEL22

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K122154

Product Code

IRP

Product Code Name

MASSAGER, POWERED INFLATABLE TUBE

Public Device Record Key

4898f61a-9f70-4857-9a98-b2efd9dc3b09

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-