VersaOne

GUDID 20884521809021

Optical Trocar with Fixation Balloon Cannula;Long

Covidien LP

Laparoscopic multi-instrument access port, single-use

• Primary Device ID: 20884521809021
• NIH Device Record Key: 73621d68-28d7-468c-accc-4e25c72656ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaOne
• Version Model Number: ONB5LGB
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521809024 [Primary]
GS1	20884521809021 [Package]; Contains: 10884521809024; Package: PACK_OR_INNER_PACK [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213818

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-27
• Device Publish Date: 2024-05-17

On-Brand Devices [VersaOne]

• 40884521215437: Universal Fixation Cannula
• 40884521215420: Universal Fixation Cannula
• 40884521215413: Universal Fixation Cannula
• 30884521621057: Blunt Trocar with Threaded Anchor
• 20884521717661: Universal Cannula Positioning Trocar System Standard
• 30884521678709: Fascial Closure System Reusable Suture Passer
• 20884521717739: Bladeless Positioning Trocar System Long
• 20884521717722: Bladeless Positioning Trocar System Standard
• 20884521717708: Bladeless Positioning Trocar System Standard
• 20884521717678: Universal Cannula Positioning Trocar System Long
• 20884521515700: Blunt Trocar with Threaded Anchor
• 20884521548104: Bladeless Trocar with Fixation Cannula
• 20884521657714: Bladeless Optical Trocar with Fixation Cannula
• 20884521657684: Bladeless Optical Trocar with Fixation Cannula
• 20884521657653: Bladeless Optical Trocar with Fixation Cannula
• 20884521657646: Bladeless Optical Trocar with Fixation Cannula
• 20884521657639: Bladeless Optical Trocar with Fixation Cannula
• 20884521657622: Bladeless Optical Trocar with Fixation Cannula
• 20884521545141: Universal Smooth Cannula
• 20884521678702: Fascial Closure System Reusable Suture Passer
• 20884521185972: Optical Trocar with Fixation Cannula
• 20884521678726: Fascial Closure System Bladed Trocar with Fixation Cannula Standard
• 20884521794426: Standard Optical Obturator
• 20884521794433: Long Optical Obturator
• 20884521785851: Long Optical Obturator
• 20884521785844: Standard Optical Obturator
• 20884521785837: Long Bladeless Obturator
• 20884521785820: Standard Bladeless Obturator
• 20884521785813: For use with Reusable Positioning Trocar System
• 10884521784079: Reusable Positioning Cannula
• 10884521784062: Reusable Positioning Cannula
• 10884521784055: Reusable Positioning Cannula
• 10884521784048: Reusable Positioning Cannula
• 10884521784031: Reusable Positioning Cannula
• 10884521784024: Reusable Positioning Cannula
• 20884521678719: Fascial Closure System Optical Trocar with Fixation Cannula, Standard
• 20884521657707: Bladeless Optical Trocar with Fixation Cannula
• 20884521657691: Bladeless Optical Trocar with Smooth Cannula
• 20884521657677: Bladeless Optical Trocar with Fixation Cannula
• 20884521657660: Bladeless Optical Trocar with Fixation Cannula
• 20884521593463: Bladed Trocar with Fixation Cannula
• 20884521548098: Bladeless Trocar with Fixation Cannula
• 20884521546919: Bladeless Trocar with Fixation Cannula
• 20884521546902: Bladeless Trocar with Fixation Cannula
• 20884521546896: Bladeless Trocar with Smooth Cannula
• 20884521546889: Bladeless Trocar with Fixation Cannula
• 20884521546872: Bladeless Trocar with Fixation Cannula
• 20884521546865: Bladeless Trocar with Fixation Cannula
• 20884521546858: Bladeless Trocar with Fixation Cannula
• 20884521546841: Bladeless Trocar with Fixation Cannula