INTRAcel RF Microneedle System

GUDID 08800020100177

Fractional RF Micro Needle System

Jeisys Medical Inc.

Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system

• Primary Device ID: 08800020100177
• NIH Device Record Key: 3bc6be7c-4566-4647-b5b8-5a3d320c0ce2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTRAcel RF Microneedle System
• Version Model Number: INTRAcel PRO
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800020100177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183284

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: 2021-01-15
• Device Publish Date: 2021-01-07

On-Brand Devices [INTRAcel RF Microneedle System]

• 08800020100184: Fractional RF Micro Needle System
• 08800020100177: Fractional RF Micro Needle System