Oval Loop Electrode

Basic Information

• Brand Name: Oval Loop Electrode
• Primary DI: 00841494101466
• Version / Model: TP8B
• Catalog Number: TP8B
• Company Name: Cynosure, LLC
• Labeler DUNS: 780318028
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 3
• Public Version Date: 2023-01-11
• Public Version Status: Update
• Public Device Record Key: fc6a5831-69fb-4cb3-8792-92bf750c0cac

Device Description

3/8" OVAL LOOP ELECTRODE REG WIRE, 1/16"

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: Yes
• PM Exempt: Yes
• 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
JOS	Electrode, electrosurgical	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
Primary	00841494101466	GS1
Unit of Use	10841494101463	GS1