Catalog Number

0386-0008-01

Brand Name

Gebauer's Pain Ease Mist Spray

Version/Model Number

0386-0008-01

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

dafa4103-51e2-4596-897c-c82db6c6c5b4

Public Version Date

March 06, 2020

Public Version Number

1

DI Record Publish Date

February 27, 2020

Package DI Number

30303860008010

Quantity per Package

24

Contains DI Package

00303860008019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-