MATTIOLI 33320060/B

GUDID 08054383090006

Pulsed Iontophoresis Device with handpiece

MATTIOLI ENGINEERING ITALIA SPA

Drug-delivery iontophoresis system, reusable

• Primary Device ID: 08054383090006
• NIH Device Record Key: 78469251-ff2d-4091-b6bc-ae219c3b22b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MATTIOLI
• Version Model Number: DEP SYSTEM PRO
• Catalog Number: 33320060/B
• Company DUNS: 514081590
• Company Name: MATTIOLI ENGINEERING ITALIA SPA
• 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: false
• Expiration Date: false
• 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	08054383090006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042590

FDA Product Code

• EGJ: Device, Iontophoresis, Other Uses

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: 2024-10-04
• Device Publish Date: 2024-09-26

On-Brand Devices [MATTIOLI]

• 08054383090013: Crystal Microdermabrasion device
• 08054383090006: Pulsed Iontophoresis Device with handpiece