Premium Poly CS

GUDID 20884521047669

C-Section Stapler with Polysorb Staples

Covidien LP

Open-surgery manual linear cutting stapler, single-use

• Primary Device ID: 20884521047669
• NIH Device Record Key: 028e177d-155c-4595-af78-7f7149badcae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premium Poly CS
• Version Model Number: 015170
• 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: 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
• 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: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch
• Length: 57 Millimeter
• Height: 0.17 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521047662 [Primary]
GS1	20884521047669 [Package]; Contains: 10884521047662; Package: CASE [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830199

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: 2021-01-14
• Device Publish Date: 2015-10-12

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• 30884522020279 - DAR: 2025-03-18 Catheter Mount
• 10884522034753 - DAR: 2025-03-18 Catheter Mount Extendable
• 10884522034791 - DAR: 2025-03-18 Catheter Mount Extendable
• 20884521066172 - DAR: 2025-03-17 Catheter Mount Extendable
• 10884521528086 - DAR: 2025-03-17 Catheter Mount
• 20884522020081 - DAR: 2025-03-17 Catheter Mount