SMK™

Basic Information

• Brand Name: SMK™
• Primary DI: 05415067028754
• Version / Model: SMK-C1510-20
• Catalog Number: SMK-C1510-20
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-10
• Public Version: 9
• Public Version Date: 2023-10-06
• Public Version Status: Update
• Public Device Record Key: a226df8d-4df4-4c99-b231-680509994e54

Device Description

Radiofrequency Cannula - Curved

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
GXD	Generator, lesion, radiofrequency	Neurology	882.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58739	Percutaneous radio-frequency ablation probe cannula, single-use	A rigid tube designed to provide percutaneous (through the skin) tissue access through its lumen for an electrosurgical probe during radio-frequency (RF) ablation procedures (typically of peripheral nerves to treat chronic pain) and for the injection/aspiration of fluids (e.g., local anaesthetic agents). It is made of metal (e.g., stainless steel), covered in insulation except for its distal tip, and includes a plastic hub; it is available in a variety of diameters and distal tip lengths/configurations. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067028754	GS1
Package	15415067028751	GS1		10	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	15	Centimeter
Needle Gauge	20	Gauge

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool and dry place; avoid exposure to extreme temperatures