PI

GUDID 30884521066513

Stapler

Covidien LP

Open-surgery manual linear cutting stapler, single-use Open-surgery manual linear cutting stapler, single-use Open-surgery manual linear cutting stapler, single-use Open-surgery manual linear cutting stapler, single-use Open-surgery manual linear cutting stapler, single-use Open-surgery manual linear cutting stapler, single-use Open-surgery manual linear cutting stapler, single-use Open-surgery manual linear cutting stapler, single-use Open-surgery manual linear cutting stapler, single-use Open-surgery manual linear cutting stapler, single-use Open-surgery manual linear cutting stapler, single-use Open-surgery manual linear cutting stapler, single-use Open-surgery manual linear cutting stapler, single-use Open-surgery manual linear cutting stapler, single-use Open-surgery manual linear cutting stapler, single-use Open-surgery manual linear cutting stapler, single-use Open-surgery manual linear cutting stapler, single-use

• Primary Device ID: 30884521066513
• NIH Device Record Key: 4c0c5e5f-d657-4abc-a5b1-988538c48a87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PI
• Version Model Number: 4901T
• 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

Device Dimensions

• Length: 30 Millimeter
• Height: 4.8 Millimeter
• Length: 30 Millimeter
• Height: 4.8 Millimeter
• Length: 30 Millimeter
• Height: 4.8 Millimeter
• Length: 30 Millimeter
• Height: 4.8 Millimeter
• Length: 30 Millimeter
• Height: 4.8 Millimeter
• Length: 30 Millimeter
• Height: 4.8 Millimeter
• Length: 30 Millimeter
• Height: 4.8 Millimeter
• Length: 30 Millimeter
• Height: 4.8 Millimeter
• Length: 30 Millimeter
• Height: 4.8 Millimeter
• Length: 30 Millimeter
• Height: 4.8 Millimeter
• Length: 30 Millimeter
• Height: 4.8 Millimeter
• Length: 30 Millimeter
• Height: 4.8 Millimeter
• Length: 30 Millimeter
• Height: 4.8 Millimeter
• Length: 30 Millimeter
• Height: 4.8 Millimeter
• Length: 30 Millimeter
• Height: 4.8 Millimeter
• Length: 30 Millimeter
• Height: 4.8 Millimeter
• Length: 30 Millimeter
• Height: 4.8 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	10884521066519 [Primary]
GS1	30884521066513 [Package]; Contains: 10884521066519; Package: CASE [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911252

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: 2023-08-15
• Device Publish Date: 2015-08-28

On-Brand Devices [PI]

• 20884521066899: Loading Unit
• 20884521066530: Loading Unit
• 20884521066523: Loading Unit
• 20884521066486: Loading Unit
• 20884521066479: Loading Unit
• 20884521066462: Loading Unit
• 20884521065168: Vascular Loading Unit
• 20884521065137: Loading Unit
• 20884521065120: Loading Unit
• 20884521065106: Vascular Loading Unit
• 30884521066513: Stapler
• 30884521066506: Stapler