SurgiStat VLSURGGENZD

GUDID 10884521546233

Low-Power Electrosurgical Generator

Covidien LP

Electrosurgical system generator

• Primary Device ID: 10884521546233
• NIH Device Record Key: 95e9f470-4e54-41ed-843b-e46d01ee76bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurgiStat
• Version Model Number: VLSURGGENZD
• Catalog Number: VLSURGGENZD
• 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: false
• Serial Number: true
• 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
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521546233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001955

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-18
• Device Publish Date: 2017-08-23

On-Brand Devices [SurgiStat]

• 10884521517417: SurgiStat Low Power Generator
• 10884521546233: Low-Power Electrosurgical Generator
• 10884521546226: Low-Power Electrosurgical Generator
• 10884521049727: Electrosurgical Generator II 120 V
• 10884521041714: Electrosurgical Generator II,110 V
• 10884521041622: Electrosurgical Generator II,120 V
• 10884521035928: Electrosurgical Generator II,240 V
• 10884521783843: Low-Power Electrosurgical Generator