GIA Premium

GUDID 10884521063402

Reusable Stapler

Covidien LP

Open-surgery manual linear stapler, reusable

• Primary Device ID: 10884521063402
• NIH Device Record Key: 81becc3d-1bf2-4399-93eb-80dfedd7b3af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GIA Premium
• Version Model Number: 030470
• 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: false
• 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
• 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: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 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
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521063402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K801590

FDA Product Code

• FHM: APPARATUS, SUTURING, STOMACH AND INTESTINAL

Sterilization

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

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

[10884521063402]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-02-01
• Device Publish Date: 2018-08-10

On-Brand Devices [GIA Premium]

• 20884521031637: Loading Unit
• 10884521063402: Reusable Stapler
• 20884523007098: Loading Unit