Catalog Number

BRZ-PSW-000-024

Brand Name

Pretreatment Skin Wipe

Version/Model Number

BRZ-PSW-000-024

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

Yes

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

K181740,K181740

Product Code

OOK

Product Code Name

Dermal Cooling Pack/Vacuum/Massager

Public Device Record Key

7ce61b41-fc75-4ec5-a947-fd29106a6215

Public Version Date

May 18, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-