60-0815-001

GUDID 40653405008492

ELECTROSURGICAL HANDPIECE

Conmed Corporation

Open-surgery electrosurgical electrode, monopolar, reusable

Primary Device ID	40653405008492
NIH Device Record Key	a5802ebd-e2df-47d7-8f59-7d30e0790f1d
Commercial Distribution Status	In Commercial Distribution
Version Model Number	60-0815-001
Catalog Number	60-0815-001
Company DUNS	071595540
Company Name	Conmed Corporation
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(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM

Operating and Storage Conditions

Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	30653405008495 [Primary]
GS1	40653405008492 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K885200

FDA Product Code

GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES