SmoothWave RF Generator IEC6-IESU200

GUDID 00810026181115

Soniquence SmoothWave i200 RF Generator

SONIQUENCE, LLC

Electrosurgical system

• Primary Device ID: 00810026181115
• NIH Device Record Key: afeabcd8-5305-4044-a96b-76e2f55a0f97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmoothWave RF Generator
• Version Model Number: IEC6-IESU200
• Catalog Number: IEC6-IESU200
• Company DUNS: 117308190
• Company Name: SONIQUENCE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810026181115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183611

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: 2021-04-15
• Device Publish Date: 2021-04-07

On-Brand Devices [SmoothWave RF Generator]

• 00810026181115: Soniquence SmoothWave i200 RF Generator
• 00810026181108: Soniquence SmoothWave i100 RF Generator