Quick-Cross™Select - Quick-Cross™Select Support Catheter - Spectranetics Corporation

Duns Number:151047370

Device Description: Quick-Cross™Select Support Catheter

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More Product Details

Catalog Number

518-093

Brand Name

Quick-Cross™Select

Version/Model Number

518-093AB

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

DQY

Product Code Name

Catheter, Percutaneous

Device Record Status

Public Device Record Key

3e4b033f-9182-412a-87b6-e58c517a36ee

Public Version Date

December 22, 2021

Public Version Number

7

DI Record Publish Date

September 04, 2015

Additional Identifiers

Package DI Number

20813132021799

Quantity per Package

5

Contains DI Package

00813132021795

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"SPECTRANETICS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 251
3 A medical device with high risk that requires premarket approval 126