Phoenix 0.014” Guidewire, Floppy Tip / Light Support - Volcano Atheromed, Inc.

Duns Number:788341084

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More Product Details

Catalog Number

-

Brand Name

Phoenix 0.014” Guidewire, Floppy Tip / Light Support

Version/Model Number

PG14300LF

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)

Yes

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

fe756b4a-7191-4684-bb00-09a958b100d8

Public Version Date

March 31, 2022

Public Version Number

5

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

00845225002763

Quantity per Package

5

Contains DI Package

10845225002760

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"VOLCANO ATHEROMED, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 26