Catalog Number

-

Brand Name

McKesson

Version/Model Number

25-402

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 07, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KYZ

Product Code Name

Syringe, Irrigating (Non Dental)

Public Device Record Key

52a31fb7-e9bb-4dee-913a-07291d8fe6f7

Public Version Date

December 08, 2021

Public Version Number

3

DI Record Publish Date

June 25, 2020

Package DI Number

40612479182606

Quantity per Package

50

Contains DI Package

10612479182599

Package Discontinue Date

December 07, 2021

Package Status

Not in Commercial Distribution

Package Type

Case