Catalog Number

-

Brand Name

McKesson

Version/Model Number

73-PP052

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

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

-

Product Code

FRC

Product Code Name

Indicator, Biological Sterilization Process

Public Device Record Key

a94f2677-dd0a-46e8-8086-d1448820161d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 09, 2016

Package DI Number

40612479159127

Quantity per Package

4

Contains DI Package

20612479159116

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case