RHYTHMLINK INTERNATIONAL, LLC

GUDID 10816312027195

24 electrodes, 1.5m blue 13mm subdermal needles

RHYTHMLINK INTERNATIONAL, LLC

Subdermal needle electrode

• Primary Device ID: 10816312027195
• NIH Device Record Key: fc90ca69-6a0e-4fee-bd18-f142e7ca7639
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RHYTHMLINK INTERNATIONAL, LLC
• Version Model Number: SN15B
• Company DUNS: 126290993
• Company Name: RHYTHMLINK INTERNATIONAL, LLC
• Device Count: 1
• 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: true
• Expiration Date: false
• 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
• 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	00816312027198 [Primary]
GS1	10816312027195 [Package]; Contains: 00816312027198; Package: [24 Units]; In Commercial Distribution

FDA Product Code

• GXZ: Electrode, Needle

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-22
• Device Publish Date: 2024-05-14

On-Brand Devices [RHYTHMLINK INTERNATIONAL, LLC]

• 00816312024401: 23 Deep Cup Electrode Harness with multipin connector
• 10816312023845: Disposable Deep EEG Cup Electrodes
• 00816312026733: Concentric Needle Cable
• 10816312027195: 24 electrodes, 1.5m blue 13mm subdermal needles
• 00816312027488: 1 Bundle of 3 Quick Connect Arrays with 27 Deep Cups, 1.5m and 2 MR Sticky Pads, 2.5m
• 00816312027600: 27 Deep Cup Electrodes, 1.5m and 2 Ground Sticky Pads, 2.5m