EEA EEATAID21D

GUDID 10884521047419

Introducer Device

Covidien LP

Rectal dilator, reusable

• Primary Device ID: 10884521047419
• NIH Device Record Key: ff0b38ee-db85-4dc5-822f-40f7c08127a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EEA
• Version Model Number: EEATAID21D
• Catalog Number: EEATAID21D
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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
• 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

• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• 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
• 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	10884521047419 [Package]; Contains: 20884521047416; Package: CASE [6 Units]; In Commercial Distribution
GS1	20884521047416 [Primary]

FDA Product Code

• FZX: Guide, surgical, instrument

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: 2018-09-18
• Device Publish Date: 2018-08-18

On-Brand Devices [EEA]

• 20884523006626: Reusable Sizer
• 10884521047419: Introducer Device
• 10884521045712: Introducer Device
• 20884523006565: Loading Unit
• 20884523006558: Loading Unit
• 20884523006541: Loading Unit
• 20884521593173: Black Circular Stapler with Tri-Staple Technology
• 20884521593159: Black Circular Stapler with Tri-Staple Technology
• 20884521593135: Black Circular Stapler with Tri-Staple Technology
• 20884521593074: Black Circular Stapler with Tri-Staple Technology
• 20884521593050: Black Circular Stapler with Tri-Staple Technology
• 20884521593036: Black Circular Stapler with Tri-Staple Technology
• 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
• 10884523004748: Circular Stapler with DST Series Technology
• 10884523004724: Circular Stapler with DST Series Technology
• 10884523004663: Circular Stapler with DST Series Technology
• 20884523006176: Circular Stapler with DST Series Technology
• 20884523006169: Circular Stapler with DST Series Technology
• 20884523006145: Circular Stapler with DST Series Technology
• 20884523006138: Circular Stapler with DST Series Technology
• 20884523006121: Circular Stapler with DST Series Technology
• 20884523006053: Circular Stapler with DST Series Technology
• 20884523005582: Circular Stapler with DST Series Technology
• 20884523005575: Circular Stapler with DST Series Technology
• 20884523005568: Circular Stapler with DST Series Technology
• 20884523005551: Circular Stapler with DST Series Technology
• 10884523004731: Circular Stapler with DST Series Technology
• 20884521047560: Hemorrhoid and Prolapse Stapler with DST Series Technology
• 20884521047515: Hemorrhoid and Prolapse Stapler with DST Series Technology
• 20884521593098: Circular Stapler with Tri-Staple Technology
• 20884521593081: Circular Stapler with Tri-Staple Technology
• 20884521592992: Circular Stapler with Tri-Staple Technology
• 20884521592985: Circular Stapler with Tri-Staple Technology
• 20884521827667: CIR STPLR TRIEEAXL25XT BLK wTRISTP nORVL
• 20884521827650: CIR STPLR TRIEEAXL25MT wTRISTP nORVL
• 20884521827643: CIR STPLR TRIEEAXL21XT BLK wTRISTP nORVL
• 20884521827636: CIR STPLR TRIEEAXL21MT wTRISTP nORVL