Tri-Staple 2.0 SIGTRSB45AMT

GUDID 20884521717609

Reinforced Intelligent Reload, For use with Signia stapling system

Covidien LP

Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting

• Primary Device ID: 20884521717609
• NIH Device Record Key: bf71a7c2-ae71-464c-ae0c-13bc2cd4a01f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tri-Staple 2.0
• Version Model Number: SIGTRSB45AMT
• Catalog Number: SIGTRSB45AMT
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521717602 [Primary]
GS1	20884521717609 [Package]; Contains: 10884521717602; Package: PACK_OR_INNER_PACK [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173270

FDA Product Code

• GDW: STAPLE, IMPLANTABLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-07
• Device Publish Date: 2018-06-30

On-Brand Devices [Tri-Staple 2.0]

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