Tri-Staple 2.0 SIGCIR33MT

GUDID 20884521703763

Medium/Thick Circular Reload For use with Signia Circular Adapters

Covidien LP

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• Primary Device ID: 20884521703763
• NIH Device Record Key: 04109245-5367-4648-a40e-17d99c6e6846
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tri-Staple 2.0
• Version Model Number: SIGCIR33MT
• Catalog Number: SIGCIR33MT
• 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: false
• 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
• 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

• Device Size Text, specify: 0
• Outer Diameter: 33 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 33 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 33 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 33 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 33 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 33 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 33 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 33 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 33 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 33 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 33 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 33 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 33 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 33 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 33 Centimeter
• Outer Diameter: 33 Centimeter
• Outer Diameter: 33 Centimeter
• Outer Diameter: 33 Centimeter
• Outer Diameter: 33 Centimeter
• Outer Diameter: 33 Centimeter
• Outer Diameter: 33 Centimeter
• Outer Diameter: 33 Centimeter
• Outer Diameter: 33 Centimeter
• Outer Diameter: 33 Centimeter
• Outer Diameter: 33 Centimeter
• Outer Diameter: 33 Centimeter
• Outer Diameter: 33 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 55 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521703766 [Primary]
GS1	20884521703763 [Package]; Contains: 10884521703766; Package: PACK_OR_INNER_PACK [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182475

FDA Product Code

• GDW: Staple, implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-08
• Device Publish Date: 2019-06-29

On-Brand Devices [Tri-Staple 2.0]

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• 20884521543550: Cartridge
• 20884521543543: Cartridge
• 20884521543536: Cartridge
• 20884521543529: Cartridge
• 20884521543512: Cartridge
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