Model: BF-FSC#
DI: 00846338000431
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
Dual Bipolar Footswitch
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
baaa894e-6132-4086-9a00-8ecd9db7a2ce
Distribution Status:
In Commercial Distribution
DUNS Number:
019872358
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00846338000431
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 36336
Name: Foot-switch, electrical
Definition:
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.
FDA Product Codes
GEI
Electrosurgical, Cutting & Coagulation & Accessories