Catalog Number

0386-0010-01

Brand Name

Gebauer's Instant Ice

Version/Model Number

0386-0010-01

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K021726,K021726

Product Code

MLY

Product Code Name

Refrigerant, Topical (Vapocoolant)

Public Device Record Key

aae0f02e-0b27-4eb2-9233-9db7700351b4

Public Version Date

March 06, 2020

Public Version Number

1

DI Record Publish Date

February 27, 2020

Package DI Number

20303860010016

Quantity per Package

12

Contains DI Package

00303860010012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-