Spacemaker Plus

GUDID 20884521067575

Dissector System

Covidien LP

Laparoscopic balloon dissector

• Primary Device ID: 20884521067575
• NIH Device Record Key: 6dad3004-f367-4dd1-8271-edf1b2a20b6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spacemaker Plus
• Version Model Number: SMBTTRND
• 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: true
• 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

Device Dimensions

• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521067578 [Primary]
GS1	20884521067575 [Package]; Contains: 10884521067578; Package: CASE [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042412

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: 2024-01-08
• Device Publish Date: 2016-09-24

On-Brand Devices [Spacemaker Plus]

• 10884521067417: Dissector System
• 20884521067834: Dissector System
• 20884521067827: Dissector System
• 20884521067575: Dissector System