RHYTHMLINK INTERNATIONAL, LLC

GUDID 10816312027195

24 electrodes, 1.5m blue 13mm subdermal needles

RHYTHMLINK INTERNATIONAL, LLC

Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode Subdermal needle electrode 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