Bi-Turbinate Probe STURB-D

GUDID 00810026180576

Bi-Turbinate Probe (Bayonet) Disposable 17.5cm (1 pc)

SONIQUENCE, LLC

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: 00810026180576
• NIH Device Record Key: f0069308-75ac-410f-b5a2-b139e4ba08d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bi-Turbinate Probe
• Version Model Number: STURB-D
• Catalog Number: STURB-D
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00810026180569 [Primary]
GS1	00810026180576 [Package]; Contains: 00810026180569; Package: case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002257

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: 2021-09-27
• Device Publish Date: 2021-09-19

On-Brand Devices [Bi-Turbinate Probe ]

• 00810026180576: Bi-Turbinate Probe (Bayonet) Disposable 17.5cm (1 pc)
• 00810026180552: Bi-Turbinate Probe (Bayonet) Reusable 17.5cm