Hybrid Energy (HE) disposable tips 30010150

GUDID 07290016586268

Hybrid Energy (HE) disposable tips gen100

POLLOGEN LTD

Radio-frequency skin contouring system applicator tip

• Primary Device ID: 07290016586268
• NIH Device Record Key: 8bc92b4a-2751-41a7-90b2-dfe8f309ff2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hybrid Energy (HE) disposable tips
• Version Model Number: gen100
• Catalog Number: 30010150
• Company DUNS: 514905681
• Company Name: POLLOGEN LTD
• Device Count: 5
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016586268 [Primary]
GS1	17290016586265 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173503

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: 2019-05-20
• Device Publish Date: 2019-05-12

On-Brand Devices [Hybrid Energy (HE) disposable tips]

• 07290016586060: gen12
• 07290016586053: gen36
• 07290016586275: Hybrid Energy (HE) disposable tips gen36L
• 07290016586268: Hybrid Energy (HE) disposable tips gen100