Bi-Turbinate Probe STURB

GUDID 00810026180552

Bi-Turbinate Probe (Bayonet) Reusable 17.5cm

SONIQUENCE, LLC

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 00810026180552
• NIH Device Record Key: c3962bfd-5d7f-4152-b629-9b1d150af2f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bi-Turbinate Probe
• Version Model Number: STURB
• Catalog Number: STURB
• 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: true
• Serial Number: false
• 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
GS1	00810026180552 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002257

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00810026180552]

Moist Heat or Steam Sterilization

[00810026180552]

Moist Heat or Steam Sterilization

[00810026180552]

Moist Heat or Steam Sterilization

[00810026180552]

Moist Heat or Steam Sterilization

[00810026180552]

Moist Heat or Steam Sterilization

[00810026180552]

Moist Heat or Steam Sterilization

[00810026180552]

Moist Heat or Steam Sterilization

[00810026180552]

Moist Heat or Steam Sterilization

[00810026180552]

Moist Heat or Steam Sterilization

[00810026180552]

Moist Heat or Steam Sterilization

[00810026180552]

Moist Heat or Steam Sterilization

[00810026180552]

Moist Heat or Steam Sterilization

[00810026180552]

Moist Heat or Steam Sterilization

[00810026180552]

Moist Heat or Steam Sterilization

[00810026180552]

Moist Heat or Steam Sterilization

[00810026180552]

Moist Heat or Steam Sterilization

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