Venus Viva applicator

GUDID 07290016540703

VENUS CONCEPT LTD

Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system Radio-frequency skin surface treatment system

• Primary Device ID: 07290016540703
• NIH Device Record Key: 1e3584b8-5652-4198-b5a1-b1bc33cbad46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venus Viva applicator
• Version Model Number: AS112011
• Company DUNS: 533127663
• Company Name: VENUS CONCEPT LTD
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016540260 [Primary]
GS1	07290016540703 [Package]; Contains: 07290016540260; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150161

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: 2018-12-19
• Device Publish Date: 2018-11-18

On-Brand Devices [Venus Viva applicator]

• 07290016540482: RF applicator intended for dermatological procedures requiring ablation and resurfacing of the s
• 07290016540376: Venus Viva applicator is designed for use in dermatological procedures requiring ablation and re
• 07290016540703: AS112011