Premium Poly CS

GUDID 20884521047669

C-Section Stapler with Polysorb Staples

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 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 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: 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

Devices Manufactured by Covidien LP

• 10884521744134 - TruClear: 2024-04-23 Calibration Insert
• 10884521744141 - TruClear: 2024-04-23 Calibration Insert
• 10884521557048 - INVOS: 2024-04-22 Docking Station
• 10884521833869 - Endoflip: 2024-04-22 Refurbished 300 Pump System With Pre-Use Tube
• 20884521140216 - ClosureFast: 2024-04-15 Compression Bandages,Cohesive,6"" x 15' (15.24 cm x 4.572 m)
• 10884521543430 - LiquiBand Exceed: 2024-04-15 2-Octyl Cyanoacrylate
• 20884521140209 - ClosureFast: 2024-04-10 Compression Bandages,Cohesive,4"" x 15' (10.16 cm x 4.572 m)
• 10884521539921 - VenaSeal: 2024-04-09 VenaSeal Closure System