Sonicision SCGAA

GUDID 10884521592865

Reusable Generator

Covidien LP

Soft-tissue ultrasonic surgical system

Primary Device ID	10884521592865
NIH Device Record Key	f6e70943-8b3d-453b-b2cc-7c3317a61703
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sonicision
Version Model Number	SCGAA
Catalog Number	SCGAA
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	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

Operating and Storage Conditions

Handling Environment Temperature	Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Temperature	Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521592865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K180149

FDA Product Code

LFL	Instrument, ultrasonic surgical