Catalog Number

0386-0008-03

Brand Name

Gebauer's Pain Ease Medium Stream

Version/Model Number

0386-0008-03

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

K172028,K172028

Product Code

MLY

Product Code Name

Refrigerant, Topical (Vapocoolant)

Public Device Record Key

4dee9f4c-aa27-4eb3-9fa6-d5eca00dbf36

Public Version Date

March 06, 2020

Public Version Number

1

DI Record Publish Date

February 27, 2020

Package DI Number

20303860008037

Quantity per Package

12

Contains DI Package

00303860008033

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-