TORAYGUIDE GUIDEWIRE - TORAY INDUSTRIES,INC.

Duns Number:690535422

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More Product Details

Catalog Number

-

Brand Name

TORAYGUIDE GUIDEWIRE

Version/Model Number

TRG-25230

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Device Record Status

Public Device Record Key

21e92138-d8d3-4a2c-be4f-ed65429d071c

Public Version Date

November 30, 2021

Public Version Number

3

DI Record Publish Date

July 22, 2016

Additional Identifiers

Package DI Number

14960685200795

Quantity per Package

1

Contains DI Package

04960685200798

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"TORAY INDUSTRIES,INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4
3 A medical device with high risk that requires premarket approval 3