Catalog Number

-

Brand Name

McKesson

Version/Model Number

68-101400

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

K930284,K930284

Product Code

MED

Product Code Name

Sterilant, Medical Devices

Public Device Record Key

9d581307-de4c-4961-827b-4bfcb442ad11

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 09, 2016

Package DI Number

40612479150575

Quantity per Package

4

Contains DI Package

10612479150567

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case