Triworks Group srl

GUDID 08057168020007

Plasma device

TRIWORKS GROUP SRL

Nitrogen plasma skin surface treatment system

• Primary Device ID: 08057168020007
• NIH Device Record Key: 18e1b25b-2558-428e-b52d-9123fe5d979a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Triworks Group srl
• Version Model Number: AgeJet
• Company DUNS: 438539915
• Company Name: TRIWORKS GROUP SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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	08057168020007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212472

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: 2023-03-14
• Device Publish Date: 2023-03-06

On-Brand Devices [Triworks Group srl]

• 08057168020083: Nitrogen Plasma system
• 08057168020007: Plasma device