Jeisys Medical Inc.

GUDID 08800020106759

DENSITY Noir Main body

Jeisys Medical Inc.

Radio-frequency skin/body contouring system

• Primary Device ID: 08800020106759
• NIH Device Record Key: de18428d-2229-4b19-acd9-f9aaccc414c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jeisys Medical Inc.
• Version Model Number: DENSITY Noir
• Company DUNS: 690275362
• Company Name: Jeisys Medical Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800020106759 [Primary]

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: 2025-09-05
• Device Publish Date: 2025-08-28

On-Brand Devices [Jeisys Medical Inc.]

• 08800020106407: ALPHA Tip
• 08800020106759: DENSITY Noir Main body