Coupling Gel

GUDID 18800016902799

CLASSYS Inc.

Electrode conductive medium

• Primary Device ID: 18800016902799
• NIH Device Record Key: 3a7904a0-b5dd-4b97-b449-e5aef07426f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coupling Gel
• Version Model Number: XG00-00010-001
• Company DUNS: 689842183
• Company Name: CLASSYS Inc.
• 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: true
• Device Combination Product: false
• Single Use: false
• 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	08800016902792 [Primary]
GS1	18800016902799 [Package]; Contains: 08800016902792; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240248

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2024-08-12
• Device Publish Date: 2024-08-03

Devices Manufactured by CLASSYS Inc.

• 08800016903683 - Secret PRO Set Package: 2024-11-08
• 08800016903690 - Secret PRO Main Unit: 2024-11-08
• 08800016903706 - Secret PRO Articulated Arm: 2024-11-08
• 08800016903713 - Secret PRO Scanner Handpiece: 2024-11-08
• 08800016903720 - Secret PRO Needle Hanpdiece: 2024-11-08
• 08800016903737 - Secret PRO Bigger Handpiece: 2024-11-08
• 08800016903744 - Secret PRO Smartcure Handpiece: 2024-11-08
• 08800016903195 - Fraxis Duo 25Pin Needle Tip: 2024-11-07