Dual Footswitch

Basic Information

• Brand Name: Dual Footswitch
• Primary DI: 00810026180927
• Version / Model: SDF-FSCB
• Catalog Number: SDF-FSCB
• Company Name: SONIQUENCE, LLC
• Labeler DUNS: 117308190
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-19
• Public Version: 1
• Public Version Date: 2021-09-27
• Public Version Status: New
• Public Device Record Key: 89c249a5-0b4f-42fb-baee-42732a992ab6

Device Description

Dual Footswitch (Monopolar Cut/Blend & Bipolar Hemo/Bipolar)

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
36336	Foot-switch, electrical	An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810026180927	GS1

Premarket Submissions

Submission Number	Supplement Number
K183611	000