Catalog Number

-

Brand Name

TORAYGUIDE GUIDEWIRE

Version/Model Number

TRG-25175

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)

-

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

c1bf4030-5141-4a21-9b8c-52ded217e8bf

Public Version Date

November 30, 2021

Public Version Number

3

DI Record Publish Date

July 22, 2016

Package DI Number

14960685200788

Quantity per Package

1

Contains DI Package

04960685200781

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-