POWER POINT PLUS 130384

GUDID 50653405041090

POWER POINT PLUS ELECTROSURGICAL HANDPIECE

Conmed Corporation

Open-surgery electrosurgical electrode, monopolar, reusable

Primary Device ID	50653405041090
NIH Device Record Key	7368cebc-92db-4138-bd91-79548f021f9b
Commercial Distribution Status	In Commercial Distribution
Brand Name	POWER POINT PLUS
Version Model Number	130384
Catalog Number	130384
Company DUNS	071595540
Company Name	Conmed Corporation
Device Count	10
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
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
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM
Phone	+1(800)237-0169
Email	CUSTOMER_SERVICE@CONMED.COM

Device Dimensions

Length	3 Meter
Length	3 Meter
Length	3 Meter
Length	3 Meter
Length	3 Meter
Length	3 Meter
Length	3 Meter
Length	3 Meter
Length	3 Meter
Length	3 Meter
Length	3 Meter
Length	3 Meter
Length	3 Meter
Length	3 Meter
Length	3 Meter
Length	3 Meter
Length	3 Meter
Length	3 Meter

Operating and Storage Conditions

Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment Temperature	Between -29 Degrees Fahrenheit and 149 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
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment Temperature	Between -29 Degrees Fahrenheit and 149 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
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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 -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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 -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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 -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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 -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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 -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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 -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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 -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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 -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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 -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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 -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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 -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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 -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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 -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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 -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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 -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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 -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment Temperature	Between -34 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405041095 [Unit of Use]
GS1	10653405041092 [Direct Marking]
GS1	40653405041093 [Primary]
GS1	50653405041090 [Package] Contains: 40653405041093 Package: CARTON [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K936075

FDA Product Code

GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES