Turbo-Power™ 423-050

GUDID 00813132026776

Turbo-Power™ Laser Atherectomy Catheter

Spectranetics Corporation

Atherectomy laser system beam guide-catheter, peripheral
Primary Device ID00813132026776
NIH Device Record Key38f0832d-18fb-45a0-896c-fd63b49ea2e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTurbo-Power™
Version Model Number423-050AB
Catalog Number423-050
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
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com
Phone(800) 228-4728
EmailIGTD.CustomerInquiry@philips.com

Device Dimensions

Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter
Outer Diameter2.3 Millimeter
Length125 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100813132026776 [Primary]

FDA Product Code

MCWCatheter, Peripheral, Atherectomy

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00813132026776]

Ethylene Oxide


[00813132026776]

Ethylene Oxide


[00813132026776]

Ethylene Oxide


[00813132026776]

Ethylene Oxide


[00813132026776]

Ethylene Oxide


[00813132026776]

Ethylene Oxide


[00813132026776]

Ethylene Oxide


[00813132026776]

Ethylene Oxide


[00813132026776]

Ethylene Oxide


[00813132026776]

Ethylene Oxide


[00813132026776]

Ethylene Oxide


[00813132026776]

Ethylene Oxide


[00813132026776]

Ethylene Oxide


[00813132026776]

Ethylene Oxide


[00813132026776]

Ethylene Oxide


[00813132026776]

Ethylene Oxide


[00813132026776]

Ethylene Oxide


[00813132026776]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-31
Device Publish Date2018-11-29

On-Brand Devices [Turbo-Power™]

00813132026783Turbo-Power™ Laser Atherectomy Catheter
00813132026776Turbo-Power™ Laser Atherectomy Catheter
00813132025397Turbo-Power™ Laser Atherectomy Catheter
00813132025366Turbo-Power™ Laser Atherectomy Catheter
00813132024833Turbo-Power™ Laser Atherectomy Catheter
00813132022983Turbo-Power™ Laser Atherectomy Catheter

Trademark Results [Turbo-Power]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TURBO-POWER
TURBO-POWER
86701531 4966361 Live/Registered
The Spectranetics Corporation
2015-07-22

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