triFX

GUDID 07290016586497

GEN100 DISPOSABLE TIP ASSY 5 PACKED BK

POLLOGEN LTD

Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip Radio-frequency skin contouring system applicator tip

• Primary Device ID: 07290016586497
• NIH Device Record Key: b1ee1ef2-429d-424c-b92b-2d27193f22b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: triFX
• Version Model Number: GEN 100
• Company DUNS: 514905681
• Company Name: POLLOGEN LTD
• Device Count: 5
• 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	07290016586497 [Unit of Use]
GS1	17290016586494 [Primary]

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: 2022-06-07
• Device Publish Date: 2022-05-30

On-Brand Devices [triFX]

• 07290016586527: GEN 12 DISPOSABLE TIP ASSY 5 PACKED BK
• 07290016586510: GEN 36 DISPOSABLE TIP ASSY 5 PACKED BK
• 07290016586503: GEN 36L DISPOSABLE TIP ASSY 5 PACKED BK
• 07290016586497: GEN100 DISPOSABLE TIP ASSY 5 PACKED BK
• 17290016586487: H7X7 DISPOSABLE TIP ASSY 5 PACKED BK