Catalog Number

-

Brand Name

MCKESSON

Version/Model Number

37-234

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

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

K813027

Product Code

KYZ

Product Code Name

Syringe, Irrigating (Non Dental)

Public Device Record Key

b8e89aa6-7a89-49ac-9d94-43a038ccf28b

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-