Epimed

Basic Information

• Brand Name: Epimed
• Primary DI: 00818788022684
• Version / Model: 300-1615
• Catalog Number: 300-1615
• Company Name: EPIMED INTERNATIONAL, INC
• Labeler DUNS: 799751953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-26
• Public Version: 4
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: da0f0455-b9b4-4564-aa83-c8a0d6136b6c

Device Description

Rulo Probe 16g x 15cm w/ 10mm Active Area

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: No
• 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
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	10818788022681	GS1	Case	5	In Commercial Distribution
Primary	00818788022684	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	10	Millimeter
Device Size Text, specify			16g
Length	15	Centimeter
Device Size Text, specify			10mm Active Tip
Needle Gauge	16	Gauge
Device Size Text, specify			15cm

Storage Conditions

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