TurboHawk THS-SX-C

GUDID 00821684047927

Peripheral Plaque Excision System;Small Vessel Extended Tip

Covidien LP

Mechanical atherectomy system catheter, peripheral
Primary Device ID00821684047927
NIH Device Record Key533a5819-be33-4de6-888e-f30adf397efe
Commercial Distribution StatusIn Commercial Distribution
Brand NameTurboHawk
Version Model NumberTHS-SX-C
Catalog NumberTHS-SX-C
Company DUNS968903703
Company NameCovidien LP
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

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Length5.9 Centimeter
Outer Diameter2.2 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length5.9 Centimeter
Outer Diameter2.2 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length5.9 Centimeter
Outer Diameter2.2 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length5.9 Centimeter
Outer Diameter2.2 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length5.9 Centimeter
Outer Diameter2.2 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length5.9 Centimeter
Outer Diameter2.2 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length5.9 Centimeter
Outer Diameter2.2 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length5.9 Centimeter
Outer Diameter2.2 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length5.9 Centimeter
Outer Diameter2.2 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length5.9 Centimeter
Outer Diameter2.2 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length5.9 Centimeter
Outer Diameter2.2 Millimeter
Device Size Text, specify0
Catheter Gauge6 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
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
GS100821684047927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCWCatheter, peripheral, atherectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2015-10-12

On-Brand Devices [TurboHawk]

00821684047941Peripheral Plaque Excision System;Small Vessel Standard Tip
00821684047934Peripheral Plaque Excision System;Small Vessel Standard Tip
00821684047927Peripheral Plaque Excision System;Small Vessel Extended Tip
00821684047217Peripheral Plaque Excision System;Large Vessel Standard Tip
00821684047200Peripheral Plaque Excision System;Large Vessel Xtended Tip with MEC Technology
00821684047156Peripheral Plaque Excision System;Large Vessel Standard Tip with MEC TechNlogy
00821684047149Peripheral Plaque Excision System;Large Vessel Xtended Tip with MEC TechNlogy

Trademark Results [TurboHawk]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TURBOHAWK
TURBOHAWK
77793330 3832940 Live/Registered
COVIDIEN LP
2009-07-30
TURBOHAWK
TURBOHAWK
75331017 2293271 Dead/Cancelled
Concurrent Computer Corporation
1997-07-25
TURBOHAWK
TURBOHAWK
73682804 1486986 Dead/Cancelled
AMERICAN PLASTIC TOYS, INC.
1987-09-08

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