VersaStep Plus VSR100812P

GUDID 20884521084176

Radially Expandable Sleeve

Covidien LP

Laparoscopic access cannula, single-use

• Primary Device ID: 20884521084176
• NIH Device Record Key: 03193dcb-fa8c-455f-af67-360fabdce7b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaStep Plus
• Version Model Number: VSR100812P
• Catalog Number: VSR100812P
• 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
• 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: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521084179 [Primary]
GS1	20884521084176 [Package]; Contains: 10884521084179; Package: CASE [6 Units]; In Commercial Distribution

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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-09
• Device Publish Date: 2016-09-24

On-Brand Devices [VersaStep Plus]

• 20884521084183: Radially Expandable Sleeve
• 20884521084176: Radially Expandable Sleeve
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• 20884521082875: Dilator and Cannula with Radially Expandable Sleeve
• 20884521082851: Dilator and Cannula with Radially Expandable Sleeve
• 20884521082844: Dilator and Cannula with Radially Expandable Sleeve
• 20884521082820: Dilator and Cannula with Radially Expandable Sleeve
• 20884521082813: Dilator and Cannula with Radially Expandable Sleeve