NEAUVIA CELL M116I1

GUDID 08057017760511

The NEAUVIA CELL is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite.

EL.EN. SPA

Microwave hyperthermia system applicator, extracorporeal

• Primary Device ID: 08057017760511
• NIH Device Record Key: 1d2b012d-19d7-429a-908f-85b7759b0e6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEAUVIA CELL
• Version Model Number: M116I1
• Catalog Number: M116I1
• Company DUNS: 436887608
• Company Name: EL.EN. 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08057017760511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183371

FDA Product Code

• PBX: Massager, Vacuum, Radio Frequency Induced Heat

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: 2020-03-16
• Device Publish Date: 2020-03-06

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