RHYTHMLINK INTERNATIONAL, LLC

GUDID 00816312024401

23 Deep Cup Electrode Harness with multipin connector

RHYTHMLINK INTERNATIONAL, LLC

Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use

• Primary Device ID: 00816312024401
• NIH Device Record Key: 84a4b3df-8ad0-4917-9f8f-c51f9e270022
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RHYTHMLINK INTERNATIONAL, LLC
• Version Model Number: RLSP533
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816312024401 [Primary]

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-20
• Device Publish Date: 2022-01-12

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