INTRAgen

GUDID 8800020105035

Electrosurgical unit

Jeisys Medical Inc.

Electrosurgical system

• Primary Device ID: 8800020105035
• NIH Device Record Key: 73f95257-60c6-4f78-8eb4-d20caee5c121
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTRAgen
• Version Model Number: INTRAgen
• Company DUNS: 690275362
• Company Name: Jeisys Medical 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800020105011 [Primary]
GS1	8800020105035 [Package]; Contains: 08800020105011; Package: Wooden crate [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142833

FDA Product Code

• OUH: Skin Resurfacing Rf Applicator

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-04-04
• Device Publish Date: 2016-10-31

Devices Manufactured by Jeisys Medical Inc.

• 08800020101525 - POTENZA: 2026-03-24 POTENZA Neutral Electrode Pad Cable
• 08800020108166 - DENSITY: 2026-03-24 DENSITY_Foot switch
• 08800020108173 - DENSITY: 2026-03-24 DENSITY Power cord
• 08800020108180 - DENSITY: 2026-03-24 DENSITY Neutral Electrode Pad cable
• 08800020108197 - DENSITY: 2026-03-24 DENSITY Handpiece holder
• 08800020108203 - DENSITY: 2026-03-24 DENSITY Handpiece cradle
• 08800020108289 - DENSITY Tip: 2026-03-24 DENSITY Tip_Classic-B Tip
• 08800020108272 - DENSITY Tip: 2026-03-24 DENSITY Tip_Classic-E Tip