Epimed

Basic Information

• Brand Name: Epimed
• Primary DI: 00818788021793
• Version / Model: 261-2015
• Catalog Number: 261-2015
• Company Name: EPIMED INTERNATIONAL, INC
• Labeler DUNS: 799751953
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-24
• Public Version: 7
• Public Version Date: 2023-08-14
• Public Version Status: Update
• Public Device Record Key: d3cb7be4-cda4-4bb3-8bb5-69a306ba1c56
• Distribution End Date: 2023-08-11

Device Description

R-F™ Cannula Blunt 20g TW x 15cm w/ 5mm Active Tip

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: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXI	PROBE, RADIOFREQUENCY LESION	Neurology	882.4725	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	00818788021793	GS1
Package	20818788021797	GS1	Case	10	Not in Commercial Distribution	2023-08-11

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K041021	000

Device Sizes

Type	Value	Unit	Text
Length	15	Centimeter
Device Size Text, specify			15cm
Length	5	Millimeter
Needle Gauge	20	Gauge
Device Size Text, specify			5mm Active Tip
Device Size Text, specify			20g

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit