RapidCross A14BX020080090

GUDID 00821684050354

PTA Rapid Exchange Balloon Dilatation Catheter

Covidien LP

Peripheral angioplasty balloon catheter, basic
Primary Device ID00821684050354
NIH Device Record Keyc5d8ca68-7fe3-4fa0-8636-fa919c1bdd3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRapidCross
Version Model NumberA14BX020080090
Catalog NumberA14BX020080090
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
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
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0
Outer Diameter2 Millimeter
Length80 Millimeter
Catheter Gauge4 French
Device Size Text, specify0

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
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
GS100821684050354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LITCatheter, angioplasty, peripheral, transluminal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-08-09
Device Publish Date2015-10-09

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00821684051078PTA Rapid Exchange Balloon Dilatation Catheter
00821684051061PTA Rapid Exchange Balloon Dilatation Catheter
00821684051054PTA Rapid Exchange Balloon Dilatation Catheter
00821684051047PTA Rapid Exchange Balloon Dilatation Catheter
00821684051030PTA Rapid Exchange Balloon Dilatation Catheter
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00821684051016PTA Rapid Exchange Balloon Dilatation Catheter
00821684051009PTA Rapid Exchange Balloon Dilatation Catheter
00821684050996PTA Rapid Exchange Balloon Dilatation Catheter
00821684050989PTA Rapid Exchange Balloon Dilatation Catheter
00821684050972PTA Rapid Exchange Balloon Dilatation Catheter
00821684050965PTA Rapid Exchange Balloon Dilatation Catheter
00821684050958PTA Rapid Exchange Balloon Dilatation Catheter
00821684050941PTA Rapid Exchange Balloon Dilatation Catheter
00821684050934PTA Rapid Exchange Balloon Dilatation Catheter
00821684050927PTA Rapid Exchange Balloon Dilatation Catheter
00821684050910PTA Rapid Exchange Balloon Dilatation Catheter
00821684050903PTA Rapid Exchange Balloon Dilatation Catheter
00821684050897PTA Rapid Exchange Balloon Dilatation Catheter
00821684050880PTA Rapid Exchange Balloon Dilatation Catheter
00821684050873PTA Rapid Exchange Balloon Dilatation Catheter
00821684050866PTA Rapid Exchange Balloon Dilatation Catheter
00821684050859PTA Rapid Exchange Balloon Dilatation Catheter
00821684050842PTA Rapid Exchange Balloon Dilatation Catheter
00821684050835PTA Rapid Exchange Balloon Dilatation Catheter
00821684050828PTA Rapid Exchange Balloon Dilatation Catheter
00821684050811PTA Rapid Exchange Balloon Dilatation Catheter
00821684050804PTA Rapid Exchange Balloon Dilatation Catheter
00821684050798PTA Rapid Exchange Balloon Dilatation Catheter
00821684050781PTA Rapid Exchange Balloon Dilatation Catheter
00821684050774PTA Rapid Exchange Balloon Dilatation Catheter
00821684050767PTA Rapid Exchange Balloon Dilatation Catheter
00821684050750PTA Rapid Exchange Balloon Dilatation Catheter
00821684050743PTA Rapid Exchange Balloon Dilatation Catheter
00821684050736PTA Rapid Exchange Balloon Dilatation Catheter
00821684050729PTA Rapid Exchange Balloon Dilatation Catheter
00821684050712PTA Rapid Exchange Balloon Dilatation Catheter
00821684050705PTA Rapid Exchange Balloon Dilatation Catheter
00821684050699PTA Rapid Exchange Balloon Dilatation Catheter
00821684050682PTA Rapid Exchange Balloon Dilatation Catheter
00821684050675PTA Rapid Exchange Balloon Dilatation Catheter
00821684050668PTA Rapid Exchange Balloon Dilatation Catheter
00821684050651PTA Rapid Exchange Balloon Dilatation Catheter
00821684050644PTA Rapid Exchange Balloon Dilatation Catheter
00821684050637PTA Rapid Exchange Balloon Dilatation Catheter
00821684050620PTA Rapid Exchange Balloon Dilatation Catheter

Trademark Results [RapidCross]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RAPIDCROSS
RAPIDCROSS
85842611 4507467 Live/Registered
Covidien LP
2013-02-06

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