Catalog Number

DYNJWE2234

Brand Name

Medline

Version/Model Number

DYNJWE2234

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

GBX

Product Code Name

CATHETER, IRRIGATION

Public Device Record Key

22fa1cba-39f0-4b27-83de-b119876c2f2e

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

January 02, 2021

Package DI Number

40080196997597

Quantity per Package

10

Contains DI Package

10080196997596

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX