POWER POINT PLUS

Basic Information

• Brand Name: POWER POINT PLUS
• Primary DI: 30653405041096
• Version / Model: 130384
• Catalog Number: 130384
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-27
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: fa096ec4-b050-499f-922e-aff463703e2b
• Distribution End Date: 2017-03-07

Device Description

POWER POINT PLUS ELECTROSURGICAL HANDPIECE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61876	Open-surgery electrosurgical electrode, monopolar, reusable	An invasive, monopolar, electrical conductor intended to be attached to an electrosurgical handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20653405041099	GS1	CARTON	10	Not in Commercial Distribution	2017-03-07
Primary	30653405041096	GS1
Unit of Use	00653405041095	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K936075	000

Device Sizes

Type	Value	Unit	Text
Length	3	Meter

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 5 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 0 – 50 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -34 – 65 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -29 – 149 Degrees Fahrenheit