Rhythmlink

GUDID 10816312024057

21 electrodes, 13mm long, 0.4mm diameter disposable twisted subdermal needle with touch proof connector

RHYTHMLINK INTERNATIONAL, LLC

Subdermal needle electrode

• Primary Device ID: 10816312024057
• NIH Device Record Key: 0342412e-845e-444c-9567-6ac47ea1c5d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rhythmlink
• Version Model Number: RLSP527
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816312024050 [Primary]
GS1	10816312024057 [Package]; Contains: 00816312024050; Package: Product Box [3 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: 2020-02-21
• Device Publish Date: 2020-02-13

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