Catalog Number

BRZ-GL1-180-008

Brand Name

CoolAdhesive Plus Pad

Version/Model Number

BRZ-GL1-180-008

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

-

Product Code

OOK

Product Code Name

Dermal Cooling Pack/Vacuum/Massager

Public Device Record Key

f22c11bd-1878-428d-b756-70b0f5ecb632

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-