superDimension SDC5

GUDID 20884521198781

Fiducial Marker;Coil

Covidien LP

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable
Primary Device ID20884521198781
NIH Device Record Key0df64c28-5ef0-412c-9de6-d9837b716c58
Commercial Distribution Discontinuation2018-04-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NamesuperDimension
Version Model NumberSDC5
Catalog NumberSDC5
Company DUNS058614483
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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
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

Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter
Length5 Millimeter
Outer Diameter0.9 Millimeter

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
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
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521198784 [Primary]
GS120884521198781 [Package]
Contains: 10884521198784
Package: CASE [5 Units]
Discontinued: 2018-04-06
Not in Commercial Distribution

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-15
Device Publish Date2016-09-24

On-Brand Devices [superDimension]

20884521200514Pre-Marked Biopsy Forceps
20884521200484Biopsy Forceps
20884521198804Fiducial Marker;3-Band
20884521198781Fiducial Marker;Coil
20884521198774Fiducial Marker;Coil
20884521197708Fiducial Marker;Coil
10884521198722Patient Sensor Patch
10884521785861superDimension Planning Station
10884521806153navigation system console
10884521582835Planning Station
10884521545588Planning Station
10884521200364iLogic inReach;Planning Laptop
20884521200477Aspirating Needle
20884521200552Triple Needle Cytology Brush;15 mm
20884521200545Triple Needle Cytology Brush;10 mm
20884521200521Marker Delivery Kit
20884521200507Pre-marked Aspirating Needle
20884521200491Pre-marked Aspirating Needle
20884521809472Aspirating Needle
20884521809519Pre-marked Aspirating Needle
20884521809588Triple Needle Cytology Brush;15 mm
20884521809571Triple Needle Cytology Brush;10 mm
20884521809540Pre-Marked Biopsy Forceps
20884521809526Pre-marked Aspirating Needle
20884521809564Marker Delivery Kit
20884521807973Patient Sensor Patch
10884521747418v7.2 upgrade kit
10884521199989Navigation System
10884521747432v7.1 Planning Software
10884521747425v7.2 Procedure Software
20884521200538Needle-tipped Cytology Brush; Aspirating Port
20884521200460Cytology Brush
20884521198798Fiducial Marker;2-Band
20884521843216Needle-tipped Cytology Brush Aspirating Port
20884521843209Pre-marked Aspirating Needle
20884521843193Pre-marked Aspirating Needle
20884521843186Aspirating Needle
20884521843179Cytology Brush
10884521199996Navigation System

Trademark Results [superDimension]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SUPERDIMENSION
SUPERDIMENSION
76139192 2971029 Live/Registered
COVIDIEN LP
2000-10-03

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