Reliamax

GUDID 10884521174887

Reusable Gastrointestinal Anastomosis Stapler

Covidien LP

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• Primary Device ID: 10884521174887
• NIH Device Record Key: 0303da4d-d074-419f-9949-0fba1b05bf04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reliamax
• Version Model Number: GIA80RS
• 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: false
• Lot Batch: true
• Serial Number: true
• 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

Device Dimensions

• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521174887 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122781

FDA Product Code

• GDW: STAPLE, IMPLANTABLE

Sterilization

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

[10884521174887]

Moist Heat or Steam Sterilization

[10884521174887]

Moist Heat or Steam Sterilization

[10884521174887]

Moist Heat or Steam Sterilization

[10884521174887]

Moist Heat or Steam Sterilization

[10884521174887]

Moist Heat or Steam Sterilization

[10884521174887]

Moist Heat or Steam Sterilization

[10884521174887]

Moist Heat or Steam Sterilization

[10884521174887]

Moist Heat or Steam Sterilization

[10884521174887]

Moist Heat or Steam Sterilization

[10884521174887]

Moist Heat or Steam Sterilization

[10884521174887]

Moist Heat or Steam Sterilization

[10884521174887]

Moist Heat or Steam Sterilization

[10884521174887]

Moist Heat or Steam Sterilization

[10884521174887]

Moist Heat or Steam Sterilization

[10884521174887]

Moist Heat or Steam Sterilization

[10884521174887]

Moist Heat or Steam Sterilization

[10884521174887]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-03-16
• Device Publish Date: 2015-10-06

On-Brand Devices [Reliamax]

• 10884521168640: Gastrointestinal Anastomosis Reload
• 10884521168633: Gastrointestinal Anastomosis Reload
• 10884521168626: Gastrointestinal Anastomosis Reload
• 10884521168619: Gastrointestinal Anastomosis Reload
• 10884521168602: Gastrointestinal Anastomosis Reload
• 10884521174894: Reusable Gastrointestinal Anastomosis Stapler
• 10884521174887: Reusable Gastrointestinal Anastomosis Stapler