POTENZA Demokit

GUDID 08800020100214

Jeisys Medical Inc.

Electrosurgical system

• Primary Device ID: 08800020100214
• NIH Device Record Key: e655b349-b989-4159-92a0-ad2077ea96bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POTENZA Demokit
• Version Model Number: Demokit
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800020100214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201685

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2021-04-06
• Device Publish Date: 2021-03-29

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