Catalog Number

-

Brand Name

McKesson

Version/Model Number

73-OPA28

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K120306,K120306

Product Code

MED

Product Code Name

Sterilant, Medical Devices

Public Device Record Key

47321c72-c41d-4d5d-ae69-2d792f0ed8f2

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

December 09, 2016

Package DI Number

40612479185997

Quantity per Package

4

Contains DI Package

10612479185989

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case