Premium Polysorb 013501L

GUDID 20884521047577

Loading Unit with Polysorb Staples

Covidien LP

Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable

• Primary Device ID: 20884521047577
• NIH Device Record Key: d463f46d-4ec5-4220-b404-8dd5272c01fd
• Commercial Distribution Discontinuation: 2020-05-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Premium Polysorb
• Version Model Number: 013501L
• Catalog Number: 013501L
• 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

Device Dimensions

• Height: 0.06 Inch
• Length: 55 Millimeter
• Height: 0.06 Inch
• Length: 55 Millimeter
• Height: 0.06 Inch
• Length: 55 Millimeter
• Height: 0.06 Inch
• Length: 55 Millimeter
• Height: 0.06 Inch
• Length: 55 Millimeter
• Height: 0.06 Inch
• Length: 55 Millimeter
• Height: 0.06 Inch
• Length: 55 Millimeter
• Height: 0.06 Inch
• Length: 55 Millimeter
• Height: 0.06 Inch
• Length: 55 Millimeter
• Height: 0.06 Inch
• Length: 55 Millimeter
• Height: 0.06 Inch
• Length: 55 Millimeter
• Height: 0.06 Inch
• Length: 55 Millimeter
• Height: 0.06 Inch
• Length: 55 Millimeter
• Height: 0.06 Inch
• Length: 55 Millimeter
• Height: 0.06 Inch
• Length: 55 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521047570 [Primary]
GS1	20884521047577 [Package]; Contains: 10884521047570; Package: CASE [6 Units]; Discontinued: 2020-05-29; Not 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: 6
• Public Version Date: 2022-12-12
• Device Publish Date: 2015-08-28

On-Brand Devices [Premium Polysorb]

• 20884521047607: Loading Unit with Polysorb Staples
• 20884521047577: Loading Unit with Polysorb Staples