VersaStep VSR101012

GUDID 10884521081024

Reusable Dilator

Covidien LP

Laparoscopic access cannula dilator Laparoscopic access cannula dilator Laparoscopic access cannula dilator Laparoscopic access cannula dilator Laparoscopic access cannula dilator Laparoscopic access cannula dilator Laparoscopic access cannula dilator Laparoscopic access cannula dilator Laparoscopic access cannula dilator Laparoscopic access cannula dilator Laparoscopic access cannula dilator Laparoscopic access cannula dilator Laparoscopic access cannula dilator Laparoscopic access cannula dilator Laparoscopic access cannula dilator Laparoscopic access cannula dilator Laparoscopic access cannula dilator Laparoscopic access cannula dilator

• Primary Device ID: 10884521081024
• NIH Device Record Key: 3ace7f5f-f7de-45d7-b1c1-852eb5b15306
• Commercial Distribution Discontinuation: 2022-01-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VersaStep
• Version Model Number: VSR101012
• Catalog Number: VSR101012
• 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

Device Dimensions

• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521081024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012539

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-28
• Device Publish Date: 2016-09-24

On-Brand Devices [VersaStep]

• 10884521093614: Insufflation Needle
• 10884521093607: Insufflation Needle
• 10884521084193: Radially Expandable Sleeve
• 10884521084162: Short Radially Expandable Sleeve
• 10884521084155: Long Radially Expandable Sleeve
• 10884521084148: Radially Expandable Sleeve
• 10884521084131: Short Radially Expandable Sleeve
• 10884521084117: Radially Expandable Sleeve
• 10884521082861: Dilator and Cannula with Radially Expandable Sleeve
• 10884521082830: Dilator and Cannula with Radially Expandable Sleeve
• 20884521082806: Dilator and Cannula with Radially Expandable Sleeve
• 10884521081062: Sterilization Tray
• 10884521081055: Reposable Sterilization Tray
• 10884521081031: Reposable Insufflation Needle
• 10884521081000: Reusable Dilator
• 10884521080980: Reusable Dilator
• 10884521080959: Reposable Dilator
• 10884521080935: Reposable Dilator
• 10884521078581: Reusable Cannula
• 10884521078574: Reusable Cannula
• 10884521078550: Reusable Cannula
• 20884521084206: Radially Expandable Sleeve
• 10884521081048: Reposable Insufflation Needle
• 10884521078567: Reusable Cannula
• 10884521080966: Reusable Dilator
• 10884521080928: Reposable Dilator
• 10884521078598: Reusable Cannula
• 10884521081024: Reusable Dilator
• 10884521081017: Reusable Dilator