EEA

GUDID 20884523006138

Circular Stapler with DST Series Technology

Covidien LP

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• Primary Device ID: 20884523006138
• NIH Device Record Key: 53e2f2a5-2be9-4f26-b8eb-756b001d642e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EEA
• Version Model Number: EEAXL28
• 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
• 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

• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Height: 4.8 Millimeter
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884523006131 [Primary]
GS1	20884523006138 [Package]; Contains: 10884523006131; Package: CASE [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062850

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: 4
• Public Version Date: 2023-07-06
• Device Publish Date: 2015-09-01

On-Brand Devices [EEA]

• 20884523006626: Reusable Sizer
• 10884521047419: Introducer Device
• 10884521045712: Introducer Device
• 20884523006565: Loading Unit
• 20884523006558: Loading Unit
• 20884523006541: Loading Unit
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• 20884521593128: Circular Stapler with Tri-Staple Technology
• 20884521593142: Circular Stapler with Tri-Staple Technology
• 20884521593067: Circular Stapler with Tri-Staple Technology
• 10884521047471: Reusable Sizer
• 20884521593111: Black Extra Thick XL Circular Stapler with Tri-Staple Technology
• 20884521593012: Black Extra Thick Circular Stapler with Tri-Staple Technology
• 20884521593005: Medium/Thick Circular Stapler with Tri-Staple Technology
• 20884521593104: Medium/Thick XL Circular Stapler with Tri-Staple Technology
• 20884521593166: Cellular Stapler with Tri-Staple Technology
• 20884521593043: Cellular Stapler with Tri-Staple Technology
• 20884521593029: Cellular Stapler with Tri-Staple Technology
• 10884523005547: Circular Stapler with DST Series Technology
• 10884523005530: Circular Stapler with DST Series Technology
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