Catalog Number

DYNJGWIRE20L

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJGWIRE20L

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

K180177,K180177

Product Code

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

c0b01b1c-4824-43a4-8c29-662fd82a4d91

Public Version Date

August 12, 2022

Public Version Number

1

DI Record Publish Date

August 04, 2022

Package DI Number

40195327188956

Quantity per Package

10

Contains DI Package

10195327188955

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE