superDimension SDMDK1000

GUDID 20884521809564

Marker Delivery Kit

Covidien LP

Bronchoscopic catheter Bronchoscopic catheter Bronchoscopic catheter Bronchoscopic catheter Bronchoscopic catheter Bronchoscopic catheter Bronchoscopic catheter Bronchoscopic catheter
Primary Device ID20884521809564
NIH Device Record Keyff4c4133-5133-40dc-80af-917f4b89abdf
Commercial Distribution StatusIn Commercial Distribution
Brand NamesuperDimension
Version Model NumberSDMDK1000
Catalog NumberSDMDK1000
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

Device Dimensions

Length125 Centimeter
Catheter Gauge5 French
Outer Diameter0.038 Inch
Length125 Centimeter
Catheter Gauge5 French
Outer Diameter0.038 Inch
Length125 Centimeter
Catheter Gauge5 French
Outer Diameter0.038 Inch
Length125 Centimeter
Catheter Gauge5 French
Outer Diameter0.038 Inch
Length125 Centimeter
Catheter Gauge5 French
Outer Diameter0.038 Inch
Length125 Centimeter
Catheter Gauge5 French
Outer Diameter0.038 Inch
Length125 Centimeter
Catheter Gauge5 French
Outer Diameter0.038 Inch
Length125 Centimeter
Catheter Gauge5 French
Outer Diameter0.038 Inch

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;

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521809567 [Primary]
GS110884521809567 [Primary]
GS110884521809567 [Primary]
GS110884521809567 [Primary]
GS110884521809567 [Primary]
GS110884521809567 [Primary]
GS110884521809567 [Primary]
GS110884521809567 [Primary]
GS120884521809564 [Package]
Contains: 10884521809567
Package: CASE [5 Units]
In Commercial Distribution
GS120884521809564 [Package]
Contains: 10884521809567
Package: CASE [5 Units]
In Commercial Distribution
GS120884521809564 [Package]
Contains: 10884521809567
Package: CASE [5 Units]
In Commercial Distribution
GS120884521809564 [Package]
Contains: 10884521809567
Package: CASE [5 Units]
In Commercial Distribution
GS120884521809564 [Package]
Contains: 10884521809567
Package: CASE [5 Units]
In Commercial Distribution
GS120884521809564 [Package]
Contains: 10884521809567
Package: CASE [5 Units]
In Commercial Distribution
GS120884521809564 [Package]
Contains: 10884521809567
Package: CASE [5 Units]
In Commercial Distribution
GS120884521809564 [Package]
Contains: 10884521809567
Package: CASE [5 Units]
In Commercial Distribution

FDA Product Code

JAKSystem, x-ray, tomography, computed
JAKSystem, x-ray, tomography, computed
JAKSystem, x-ray, tomography, computed
JAKSystem, x-ray, tomography, computed
JAKSystem, x-ray, tomography, computed
JAKSystem, x-ray, tomography, computed
JAKSystem, x-ray, tomography, computed
JAKSystem, x-ray, tomography, computed

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

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

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