Bovie

Basic Information

• Brand Name: Bovie
• Primary DI: 10887482177263
• Version / Model: AA04X
• Company Name: ASPEN SURGICAL PRODUCTS, INC.
• Labeler DUNS: 027680821
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-28
• Public Version: 3
• Public Version Date: 2025-10-29
• Public Version Status: Update
• Public Device Record Key: 7782f852-7180-495d-ade1-5247411e1f33

Device Description

Cautery Lo-Temp Elongated Fine Tip

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HQP	Unit, Cautery, Thermal, Battery-Powered	Ophthalmic	886.4115	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35029	Electrocautery system generator, battery-powered	A battery-powered device that produces and delivers a regulated electrical current used to heat the electrode tip or wire loop of a cutting instrument used during surgical intervention to burn or sear body tissue. It is used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts, the removal of gastrointestinal polyps via an appropriate endoscope, or to occlude fallopian tubes during sterilization procedures. It will typically contain electronic circuits and have a built-in thermocoupler to help control the temperature at the electrode. This is not an electrosurgical diathermy system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00887482177273	GS1		10	In Commercial Distribution
Primary	10887482177263	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K945763	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 75 Percent (%) Relative Humidity