NA

Basic Information

• Brand Name: NA
• Primary DI: 08714729968122
• Version / Model: RFG-1B-120VH
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• Labeler DUNS: 824951958
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-11
• Public Version: 3
• Public Version Date: 2018-10-08
• Public Version Status: Update
• Public Device Record Key: 90da7caa-fea1-4c64-acf7-9e8c06b418ec

Device Description

RFG-1B RADIOFREQUENCY GEN 120V KIT CUST

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: 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
GXD	GENERATOR, LESION, RADIOFREQUENCY	Neurology	882.4400	2
GXI	PROBE, RADIOFREQUENCY LESION	Neurology	882.4725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57972	Radio-frequency ablation system	An assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729968122	GS1