Catalog Number

DYNJGWIRE25

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJGWIRE25

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

-

Product Code

OCY

Product Code Name

Endoscopic guidewire, gastroenterology-urology

Public Device Record Key

b983b379-43cd-4ee7-8712-a0bfdce697d4

Public Version Date

August 12, 2022

Public Version Number

1

DI Record Publish Date

August 04, 2022

Package DI Number

40889942857761

Quantity per Package

10

Contains DI Package

10889942857760

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE