Tri-Staple 2.0 SIGCIR28MT

GUDID 20884521703725

Medium/Thick Circular Reload For use with Signia Circular Adapters

Covidien LP

Surgical staple loading unit, cutting
Primary Device ID20884521703725
NIH Device Record Key3cff7ad2-6e1a-407d-b44b-78926b8306d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameTri-Staple 2.0
Version Model NumberSIGCIR28MT
Catalog NumberSIGCIR28MT
Company DUNS058614483
Company NameCovidien LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Dimensions

Outer Diameter28 Centimeter
Device Size Text, specify0
Outer Diameter28 Centimeter
Device Size Text, specify0
Outer Diameter28 Centimeter
Device Size Text, specify0
Outer Diameter28 Centimeter
Device Size Text, specify0
Outer Diameter28 Centimeter
Device Size Text, specify0
Outer Diameter28 Centimeter
Device Size Text, specify0
Outer Diameter28 Centimeter
Device Size Text, specify0
Outer Diameter28 Centimeter
Device Size Text, specify0
Outer Diameter28 Centimeter
Device Size Text, specify0
Outer Diameter28 Centimeter
Device Size Text, specify0
Outer Diameter28 Centimeter
Device Size Text, specify0
Outer Diameter28 Centimeter
Device Size Text, specify0
Outer Diameter28 Centimeter
Device Size Text, specify0
Outer Diameter28 Centimeter
Device Size Text, specify0
Outer Diameter28 Centimeter
Outer Diameter28 Centimeter
Outer Diameter28 Centimeter
Outer Diameter28 Centimeter
Outer Diameter28 Centimeter
Outer Diameter28 Centimeter
Outer Diameter28 Centimeter
Outer Diameter28 Centimeter
Outer Diameter28 Centimeter
Outer Diameter28 Centimeter
Outer Diameter28 Centimeter
Outer Diameter28 Centimeter
Outer Diameter28 Centimeter
Outer Diameter28 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Storage Environment TemperatureBetween 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521703728 [Primary]
GS120884521703725 [Package]
Contains: 10884521703728
Package: PACK_OR_INNER_PACK [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GDWStaple, implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-08
Device Publish Date2019-06-29

On-Brand Devices [Tri-Staple 2.0]

20884521543765Radial Intelligent Reload
20884521543758Black Radial Intelligent Reload
20884521543741Curved Tip Intelligent Reload and Introducer
20884521543727Curved Tip Intelligent Reload and Introducer
20884521543710Curved Tip Intelligent Reload and Introducer
20884521543666Intelligent Reload
20884521543642Reinforced Intelligent Reload
20884521543635Reinforced Intelligent Reload
20884521543628Black Reinforced Intelligent Reload
20884521543611Black Reinforced Intelligent Reload
20884521717630Black Reinforced Intelligent Reload, For use with Signia stapling system
20884521717623Reinforced Intelligent Reload, For use with Signia stapling system
20884521717616Black Reinforced Intelligent Reload, For use with Signia stapling system
20884521717609Reinforced Intelligent Reload, For use with Signia stapling system
20884521543772Radial Intelligent Reload
20884521543734Gray Curved Tip Intelligent Reload and Introducer
20884521543703Gray Curved Tip Intelligent Reload and Introducer
20884521543697Curved Tip Intelligent Reload and Introducer
20884521543680Curved Tip Intelligent Reload and Introducer
20884521543673Gray Intelligent Reload
20884521543659Intelligent Reload
20884521543604Black Intelligent Reload
20884521543598Black Intelligent Reload
20884521543581Cartridge
20884521543574Cartridge
20884521543567Cartridge
20884521543550Cartridge
20884521543543Cartridge
20884521543536Cartridge
20884521543529Cartridge
20884521543512Cartridge
20884521703800Circular Reload For use with Signia Circular Adapters; Medium/Thick
20884521703787Circular Reload For use with Signia Circular Adapters; Medium/Thick
20884521703763Medium/Thick Circular Reload For use with Signia Circular Adapters
20884521703749Medium/Thick Circular Reload For use with Signia Circular Adapters
20884521703725Medium/Thick Circular Reload For use with Signia Circular Adapters
20884521703718Irrigation Channel; For use with Circular Reloads
20884521808994Gray Intelligent Reload;Gray Extra Thin/Vascular Intelligent Reload;For use with Signia (TM) sta
20884521808987Intelligent Reload;Vascular/Medium Intelligent Reload;For use with Signia (TM) stapling system
20884521808970Intelligent Reload;Medium/Thick Intelligent Reload;For use with Signia (TM) stapling system
20884521808963Intelligent Reload;Vascular/Medium Intelligent Reload;For use with Signia (TM) stapling system
20884521808956Intelligent Reload;Medium/Thick Intelligent Reload;For use with Signia (TM) stapling system

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