Quick-Cross™Extreme™ 518-090

GUDID 20813132020594

Quick-Cross™Extreme™ Support Catheter

Spectranetics Corporation

Vascular guide-catheter, single-use
Primary Device ID20813132020594
NIH Device Record Keyd9149705-56eb-4315-9985-5ed36814edb8
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuick-Cross™Extreme™
Version Model Number518-090AA
Catalog Number518-090
Company DUNS151047370
Company NameSpectranetics Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com

Device Dimensions

Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter
Length135 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100813132020590 [Primary]
GS120813132020594 [Package]
Contains: 00813132020590
Package: Box [5 Units]
In Commercial Distribution
HIBCCM204518090AA0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20813132020594]

Ethylene Oxide


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[20813132020594]

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[20813132020594]

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[20813132020594]

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[20813132020594]

Ethylene Oxide


[20813132020594]

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[20813132020594]

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[20813132020594]

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[20813132020594]

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[20813132020594]

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[20813132020594]

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[20813132020594]

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[20813132020594]

Ethylene Oxide


[20813132020594]

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[20813132020594]

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[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

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[20813132020594]

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[20813132020594]

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[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


[20813132020594]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-01-23
Device Publish Date2015-02-06

On-Brand Devices [Quick-Cross™Extreme™]

M204518076AB0Quick-Cross™Extreme™ Support Catheter
M204518092AB0Quick-Cross™Extreme™ Support Catheter
M204518090AB0Quick-Cross™Extreme™ Support Catheter
M204518088AB0Quick-Cross™Extreme™ Support Catheter
M204518086AB0Quick-Cross™Extreme™ Support Catheter
M204518084AB0Quick-Cross™Extreme™ Support Catheter
M204518082AB0Quick-Cross™Extreme™ Support Catheter
M204518080AB0Quick-Cross™Extreme™ Support Catheter
M204518078AB0Quick-Cross™Extreme™ Support Catheter
20813132020617Quick-Cross™Extreme™ Support Catheter
20813132020594Quick-Cross™Extreme™ Support Catheter
20813132020570Quick-Cross™Extreme™ Support Catheter
20813132020556Quick-Cross™Extreme™ Support Catheter
20813132020532Quick-Cross™Extreme™ Support Catheter
20813132020518Quick-Cross™Extreme™ Support Catheter
20813132020495Quick-Cross™Extreme™ Support Catheter
20813132020471Quick-Cross™Extreme™ Support Catheter
20813132020457Quick-Cross™Extreme™ Support Catheter
M2045180921Quick-Cross™Extreme™ Support Catheter
M2045180901Quick-Cross™Extreme™ Support Catheter
M2045180881Quick-Cross™Extreme™ Support Catheter
M2045180861Quick-Cross™Extreme™ Support Catheter
M2045180841Quick-Cross™Extreme™ Support Catheter
M2045180821Quick-Cross™Extreme™ Support Catheter
M2045180801Quick-Cross™Extreme™ Support Catheter
M2045180781Quick-Cross™Extreme™ Support Catheter
M2045180761Quick-Cross™Extreme™ Support Catheter

Trademark Results [Quick-Cross]

Mark Image

Registration | Serial
Company
Trademark
Application Date
QUICK-CROSS
QUICK-CROSS
78278418 2928706 Live/Registered
The Spectranetics Corporation
2003-07-24

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