INTRAcel RF Microneedle System

GUDID 08800020100177

Fractional RF Micro Needle System

Jeisys Medical Inc.

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