Catalog Number

DYNJZ42972

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJZ42972

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"

-

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

K823920,K823920

Product Code

DXT

Product Code Name

Injector and syringe, angiographic

Public Device Record Key

ce518e61-c794-4baa-b860-2d7554fb7f92

Public Version Date

August 12, 2022

Public Version Number

1

DI Record Publish Date

August 04, 2022

Package DI Number

40193489897853

Quantity per Package

50

Contains DI Package

10193489897852

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE