NA

Basic Information

• Brand Name: NA
• Primary DI: 00813250017625
• Version / Model: PALISADE-18
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• Labeler DUNS: 824951958
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-27
• Public Version: 3
• Public Version Date: 2018-10-08
• Public Version Status: Update
• Public Device Record Key: 6922a166-6b7b-4a14-b60c-901c267572e1

Device Description

Palisade-18G, 4 TCD-10 and 6 CC101018

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
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	00813250017625	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			18 ga Diameter