BOVIE®

Basic Information

• Brand Name: BOVIE®
• Primary DI: 00607151012168
• Version / Model: H10108
• Catalog Number: H10108
• Company Name: BOVIE MEDICAL CORPORATION
• Labeler DUNS: 079940465
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-15
• Public Version: 3
• Public Version Date: 2019-02-07
• Public Version Status: Update
• Public Device Record Key: fa07f716-ff12-4e18-b3d3-db4cc6cc14b6

Device Description

H-TYPE BLUNT TIP DISPOSABLE DERMAL ELECTRODE, STERILE

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	884.4120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61874	Open-surgery electrosurgical electrode, monopolar, single-use	An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/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 single-use device intended to be used in a sterile condition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00607151012168	GS1
Package	10607151012165	GS1	BOX	50	In Commercial Distribution

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 10 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Fahrenheit