NA

Basic Information

• Brand Name: NA
• Primary DI: 20653405014376
• Version / Model: 714
• Catalog Number: 714
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 63f7cc9f-d78a-482e-bd76-528111c9a0fd
• Distribution End Date: 2020-09-01

Device Description

EPILATION/TELANGIECTASIAS NEEDLE 30 DEGREE ANGLE, 3/8 Inch NEEDLE ELECTRODE

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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
44680	Electrosurgical handpiece, reusable	A hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to the generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	10653405014379	GS1
Package	30653405014373	GS1	POUCH	6	Not in Commercial Distribution	2020-09-01
Primary	20653405014376	GS1
Unit of Use	00653405014372	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	0.375	Inch

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 29 – 149 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 5 – 70 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 34 – 65 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: – 85 Percent (%) Relative Humidity