Serene Medical

GUDID B653RFG100TC0

SERENE MEDICAL, INC.

Radio-frequency ablation system generator Radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator

• Primary Device ID: B653RFG100TC0
• NIH Device Record Key: a2868647-a6f8-426b-a723-b53cab5a9dd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Serene Medical
• Version Model Number: RFG-100.TC
• Company DUNS: 045060651
• Company Name: SERENE MEDICAL, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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
HIBCC	B653RFG100TC0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081729

FDA Product Code

• GXD: Generator, Lesion, Radiofrequency

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: 2019-01-01
• Device Publish Date: 2018-12-01

On-Brand Devices [Serene Medical]

• B653RFG100TC0: RFG-100.TC
• B653PB100T0: PB-100T