EEA OrVil EEAORVIL25

GUDID 10884521042865

Transoral Circular Stapler Anvil

Covidien LP

Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use Intraluminal circular stapler, single-use

• Primary Device ID: 10884521042865
• NIH Device Record Key: 80b8bbe9-c542-40b3-80b2-a6bde8338d15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EEA OrVil
• Version Model Number: EEAORVIL25
• Catalog Number: EEAORVIL25
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Device Dimensions

• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter

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	10884521042865 [Package]; Contains: 20884521042862; Package: BX [3 Units]; In Commercial Distribution
GS1	20884521042862 [Primary]

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-22

On-Brand Devices [EEA OrVil]

• 10884521042865: Transoral Circular Stapler Anvil
• 20884521042855: Transoral Circular Stapler Anvil
• 20884521042879: Transoral Circular Stapler Anvil
• 20884521042848: Transoral Circular Stapler Anvil