Polysorb 160045

GUDID 10884521176904

Drill Guide

Covidien LP

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 10884521176904
• NIH Device Record Key: 6f51e12b-0c1b-4cc2-a3f1-f45bafef58f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polysorb
• Version Model Number: 160045
• Catalog Number: 160045
• 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: 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

Device Dimensions

• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521176904 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961578

FDA Product Code

• JDR: STAPLE, FIXATION, BONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-22
• Device Publish Date: 2015-08-28

On-Brand Devices [Polysorb]

• 10884521049543: Braided Absorbable Suture
• 10884521048478: Braided Absorbable Suture
• 10884521042629: Braided Absorbable Suture
• 10884521176836: Meniscal Stapler Up Curved Loading Unit
• 10884521176829: Meniscal Stapler Straight Loading Unit
• 10884521126831: Absorbable Single Stitch Reload
• 10884521126824: Absorbable Single Stitch Reload
• 10884521126817: Absorbable Single Stitch Reload
• 10884521126800: Absorbable Single Stitch Reload
• 10884521126794: Absorbable Single Stitch Reload
• 10884521126787: Absorbable Single Stitch Reload
• 10884521126770: Absorbable Single Stitch Reload
• 10884521126763: Absorbable Single Stitch Reload
• 10884521126756: Absorbable Single Stitch Reload
• 10884521126749: Absorbable Single Stitch Reload
• 10884521126732: Absorbable Single Stitch Reload
• 10884521126619: Absorbable Single Stitch Reload
• 10884521126602: Absorbable Single Stitch Reload
• 10884521126596: Absorbable Single Stitch Reload
• 10884521126589: Absorbable Single Stitch Reload
• 10884521126572: Absorbable Single Stitch Reload
• 20884521133577: Braided Absorbable Suture
• 20884521130767: Braided Absorbable Suture
• 20884521130750: Braided Absorbable Suture
• 20884521130712: Braided Absorbable Suture
• 20884521130682: Braided Absorbable Suture
• 20884521130675: Braided Absorbable Suture
• 20884521046211: Braided Absorbable Suture
• 20884521045474: Braided Absorbable Suture
• 10884521181625: Bone Punch
• 10884521176966: Obturator
• 10884521176942: Twist Drill bit
• 10884521176935: Drill Bit
• 10884521176904: Drill Guide
• 20884521184050: Braided Absorbable Suture
• 20884521048840: Braided Absorbable Suture
• 20884521046952: Braided Absorbable Suture
• 20884521043760: Braided Absorbable Suture
• 20884521139555: Braided Absorbable Suture
• 20884521135137: Braided Absorbable Suture
• 20884521130781: Braided Absorbable Suture
• 20884521130743: Braided Absorbable Suture
• 20884521130606: Braided Absorbable Suture
• 20884521120157: Braided Absorbable Suture
• 20884521101743: Braided Absorbable Suture
• 20884521044255: Braided Absorbable Suture
• 20884521043562: Braided Absorbable Suture
• 20884521043517: Braided Absorbable Suture
• 20884521042725: Braided Absorbable Suture
• 20884521042664: Braided Absorbable Suture