Fraxis Duo 25Pin Needle Tip

GUDID 08800016903195

CLASSYS Inc.

Intradermal radio-frequency ablation system

• Primary Device ID: 08800016903195
• NIH Device Record Key: d020362d-46d9-473e-ba9e-d1b450d99357
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fraxis Duo 25Pin Needle Tip
• Version Model Number: MTR-AC-25
• Company DUNS: 689842183
• Company Name: CLASSYS 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800016903195 [Primary]
GS1	08800023200058 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160312

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-07
• Device Publish Date: 2024-10-30

Devices Manufactured by CLASSYS Inc.

• 08800016905366 - VOLNEWMER S tip: 2025-06-24
• 08800016905373 - VOLNEWMER V tip: 2025-06-24
• 08800016905380 - VOLNEWMER F tip: 2025-06-24
• 08800016905397 - VOLNEWMER I tip: 2025-06-24
• 08800016905403 - VOLNEWMER S tip(D): 2025-06-24
• 08800016905410 - VOLNEWMER V tip(D): 2025-06-24
• 08800016905427 - VOLNEWMER F tip(D): 2025-06-24
• 08800016905434 - VOLNEWMER I tip(D): 2025-06-24