POWER POINT PLUS 130384

GUDID 20653405041099

POWER POINT PLUS ELECTROSURGICAL HANDPIECE

Conmed Corporation

Open-surgery electrosurgical electrode, monopolar, reusable

• Primary Device ID: 20653405041099
• NIH Device Record Key: fa096ec4-b050-499f-922e-aff463703e2b
• Commercial Distribution Discontinuation: 2017-03-07
• Commercial Distribution Status: Not 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

Device Dimensions

• Length: 3 Meter
• Length: 3 Meter

Operating and Storage Conditions

• 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 Humidity: Between 0 Percent (%) Relative Humidity and 50 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 Temperature: Between -29 Degrees Fahrenheit and 149 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 Humidity: Between 0 Percent (%) Relative Humidity and 50 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 Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405041095 [Unit of Use]
GS1	20653405041099 [Package]; Contains: 30653405041096; Package: CARTON [10 Units]; Discontinued: 2017-03-07; Not in Commercial Distribution
GS1	30653405041096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K936075

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-27

On-Brand Devices [POWER POINT PLUS]

• 50653405041090: POWER POINT PLUS ELECTROSURGICAL HANDPIECE
• 20653405041099: POWER POINT PLUS ELECTROSURGICAL HANDPIECE