Catalog Number

-

Brand Name

McKesson

Version/Model Number

140-MST

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"

Yes

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

-

Product Code

MLY

Product Code Name

Refrigerant, Topical (Vapocoolant)

Public Device Record Key

096348ff-2b02-40b4-aa08-08491fe584f0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 02, 2017

Package DI Number

40612479221824

Quantity per Package

12

Contains DI Package

10612479220598

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case