Catalog Number

-

Brand Name

ASAHI Gladius Mongo14 ES

Version/Model Number

AP14R324P

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

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

1d99312c-f981-43cf-b6a3-c3998b84c96f

Public Version Date

November 22, 2019

Public Version Number

4

DI Record Publish Date

August 31, 2018

Package DI Number

14547327123751

Quantity per Package

5

Contains DI Package

04547327123754

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-