Catalog Number

-

Brand Name

ASAHI Silverway

Version/Model Number

SA0035N20S

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

060108e9-8355-4b2d-9cb0-654c96afac5e

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

August 09, 2019

Package DI Number

14547327121603

Quantity per Package

5

Contains DI Package

04547327121606

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-