Rhythmlink SPDC0615

GUDID 10816312023494

6 - 10mm, silver/silver-chloride 1.5m

RHYTHMLINK INTERNATIONAL, LLC

Analytical scalp electrode, single-use

• Primary Device ID: 10816312023494
• NIH Device Record Key: d29c7c05-a659-4f62-b9a0-06f2e36945c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rhythmlink
• Version Model Number: SPDC0615
• Catalog Number: SPDC0615
• Company DUNS: 126290993
• Company Name: RHYTHMLINK INTERNATIONAL, LLC
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816312023497 [Unit of Use]
GS1	10816312023494 [Primary]

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-08-27
• Device Publish Date: 2017-09-06

On-Brand Devices [Rhythmlink]

• 10816312023821: Disposable Deep EEG Cup Electrodes
• 10816312024057: 21 electrodes, 13mm long, 0.4mm diameter disposable twisted subdermal needle with touch proof co
• 10816312022473: Disposable Deep EEG Cup Electrodes
• 10816312023500: 18 - 10mm, silver/silver-chloride 1.0m
• 10816312023494: 6 - 10mm, silver/silver-chloride 1.5m
• 10816312023227: Disposable Slim EEG Cup Electrodes
• 10816312024842: 25 Ground/Reference Needle Electrodes, EMG, 12mm x 28g