Catalog Number

DYNJ26126A

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJ26126A

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

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

OEQ

Product Code Name

Angiography/angioplasty kit

Public Device Record Key

6bba13f2-e6fa-458f-b36c-cb76ef120429

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

September 29, 2016

Package DI Number

40080196017431

Quantity per Package

10

Contains DI Package

10080196017430

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE