VOLNEWMER V tip

GUDID 08800016902716

CLASSYS Inc.

Radio-frequency skin contouring system applicator tip

• Primary Device ID: 08800016902716
• NIH Device Record Key: 4fdab4b4-94d8-435f-bef4-dcad03f4944e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOLNEWMER V tip
• Version Model Number: VLMC40001
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	08800016902716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240248

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: 2024-08-12
• Device Publish Date: 2024-08-03

On-Brand Devices [VOLNEWMER V tip]

• 08800016902716: VLMC40001
• 08800016905373: VLMC04002R