Spacemaker Plus SMBTTOVL

GUDID 10884521067417

Dissector System

Covidien LP

Laparoscopic multi-instrument access port, single-use

• Primary Device ID: 10884521067417
• NIH Device Record Key: e888aee1-cf21-4f49-8cc8-1888d1b9d87b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spacemaker Plus
• Version Model Number: SMBTTOVL
• Catalog Number: SMBTTOVL
• 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
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Outer Diameter: 5 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521067417 [Primary]
GS1	20884521067414 [Package]; 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: 6
• Public Version Date: 2019-04-22
• Device Publish Date: 2016-09-24

On-Brand Devices [Spacemaker Plus]

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