LCCS

Basic Information

• Brand Name: LCCS
• Primary DI: 04895233605131
• Version / Model: RE25150-D-LC
• Company Name: LCCS Products Limited
• Labeler DUNS: 663190222
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-24
• Public Version: 3
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: b4eeb7b9-9298-4483-8cf2-f4e9572774b2

Device Description

LCCS Radiofrequency (RF) Electrode

Device Characteristics

• Single Use: Yes
• 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: 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
61931	Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use	A hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under external image guidance or using electrical stimulation for nerve location] to deliver radio-frequency current, in a monopolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal monopolar electrode which may include temperature-sensing elements; the introduction cannula or a tubing set to allow fluid cooling of the electrode may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14895233605138	GS1	Box	5	In Commercial Distribution
Primary	04895233605131	GS1
Package	64895233605133	GS1	Carton	40	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K152642	000