NeoGen 830-057

GUDID 15060440520232

NeoGen 5mm 3x Nozzle (Black)

ENERGIST LIMITED

Nitrogen plasma skin surface treatment system

• Primary Device ID: 15060440520232
• NIH Device Record Key: f01a14df-29dc-4971-ad1e-33fb9ff5ca2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoGen
• Version Model Number: NeoGen 5mm 3x Nozzle (Black)
• Catalog Number: 830-057
• Company DUNS: 735769528
• Company Name: ENERGIST LIMITED
• 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: true
• Serial Number: false
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060440520235 [Primary]
GS1	15060440520232 [Package]; Contains: 05060440520235; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132754

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: 2019-04-10
• Device Publish Date: 2019-04-02

On-Brand Devices [NeoGen]

• 05060440520099: A mobile assembly of devices intended to treat a variety of skin conditions (e.g., acne scars, a
• 15060440520249: NeoGen 25mm 3x Nozzle (Black)
• 15060440520232: NeoGen 5mm 3x Nozzle (Black)
• 15060440520263: NeoGen 25mm 3x Nozzle (Grey)
• 15060440520256: NeoGen 5mm 3x Nozzle (Grey)
• 15060440520225: NeoGen 25mm 1x Nozzle (Grey)
• 15060440520218: NeoGen 5mm 1x Nozzle (Grey)
• 15060440520201: NeoGen 25mm 1x Nozzle (Black)
• 15060440520195: NeoGen 5mm 1x Nozzle (Black)
• 05060440520280: Neogen Trolley Complete Gry
• 05060440520273: Neogen Trolley Complete Blk
• 05060440520129: Handpiece Complete (Grey)
• 05060440520105: Neogen Handpiece Complete (Black)
• 05060440520334: Grey trolley (new logo)