INTRAcel Tip

GUDID 28800020101024

Sterile micro needle electrode

Jeisys Medical Inc.

Electrosurgical system

• Primary Device ID: 28800020101024
• NIH Device Record Key: 0b0274f6-cd83-4204-ba3a-83d49776098b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTRAcel Tip
• Version Model Number: 1011
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800020101020 [Primary]
GS1	18800020101027 [Package]; Contains: 08800020101020; Package: box [10 Units]; In Commercial Distribution
GS1	28800020101024 [Package]; Contains: 18800020101027; Package: box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153727

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-26
• Device Publish Date: 2016-10-03

Devices Manufactured by Jeisys Medical Inc.

• 18800020105506 - POTENZA Tip: 2025-05-27 POTENZA Tip (Sterile micro needle electrode CP-25 Tip)
• 18800020105612 - POTENZA Tip: 2025-05-27 POTENZA Tip (Sterile micro needle electrode CP-16 Tip)
• 18800020105629 - POTENZA Tip: 2025-05-27 POTENZA Tip (Sterile micro needle electrode CP-49 Tip)
• 18800020106299 - POTENZA Tip: 2025-05-27 POTENZA Tip (DDR Tip)
• 08800020106308 - POTENZA Tip: 2025-05-27 POTENZA Tip (SFA Tip)
• 18800020106312 - POTENZA Tip: 2025-05-27 POTENZA Tip (DIA Tip)
• 08800020103536 - DENZA Main body: 2023-09-06 Radio-frequency skin contouring system
• 08800020103918 - DENZA B-Tip II: 2023-09-06 DENZA B-Tip II