Turbo-Booster™ 518-043

GUDID M2045180431

Turbo-Booster™ Laser Guide Catheter

Spectranetics Corporation

Vascular guide-catheter, single-use
Primary Device IDM2045180431
NIH Device Record Key4fc92a7d-44ed-4757-85b9-15529b219106
Commercial Distribution Discontinuation2019-02-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTurbo-Booster™
Version Model Number518-043
Catalog Number518-043
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

Device Dimensions

Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch
Lumen/Inner Diameter0.094 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM2045180430 [Primary]
HIBCCM2045180431 [Package]
Contains: M2045180430
Package: Box [3 Units]
Discontinued: 2019-02-06
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PDUCatheter For Crossing Total Occlusions

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


[M2045180431]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2020-07-23
Device Publish Date2014-09-15

On-Brand Devices [Turbo-Booster™]

20813132020280Turbo-Booster™ Laser Guide Catheter
20813132020273Turbo-Booster™ Laser Guide Catheter
M2045180631Turbo-Booster™ Laser Guide Catheter
M2045180431Turbo-Booster™ Laser Guide Catheter

Trademark Results [Turbo-Booster]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TURBO-BOOSTER
TURBO-BOOSTER
86372379 4712538 Live/Registered
The Spectranetics Corporation
2014-08-20
TURBO-BOOSTER
TURBO-BOOSTER
78856812 3354066 Dead/Cancelled
The Spectranetics Corporation
2006-04-07
TURBO-BOOSTER
TURBO-BOOSTER
73288937 1183688 Dead/Cancelled
Maremont Corporation
1980-12-08

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