Catalog Number

-

Brand Name

McKesson

Version/Model Number

73-ST48

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K191741,K191741

Product Code

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Public Device Record Key

7cbddcdd-d370-4cae-b014-e5d597d6d12f

Public Version Date

December 02, 2019

Public Version Number

1

DI Record Publish Date

November 22, 2019

Package DI Number

40612479246704

Quantity per Package

24

Contains DI Package

10612479246697

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case