Rhythmlink®

Basic Information

• Brand Name: Rhythmlink®
• Primary DI: 00816312025071
• Version / Model: 110-725
• Company Name: RHYTHMLINK INTERNATIONAL, LLC
• Labeler DUNS: 126290993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-28
• Public Version: 1
• Public Version Date: 2023-01-05
• Public Version Status: New
• Public Device Record Key: cae20aaa-d4a2-4352-a23e-d7493dd8b1f5

Device Description

35 Detachable Monopolar Needle Electrodes, EMG, 25mm x 27g with 2 Detachable Reusable Adapter Cables

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: Yes
• 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
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	890.1385	2
IKD	Cable, Electrode	Physical Medicine	890.1175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11441	Electromyographic needle electrode, single-use	A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816312025071	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	27	Gauge