Bipolar Forceps SBF-011D-10

GUDID 00810026180842

Bipolar Forceps sterile, Bayonet, 6 1/2", 1.0mm tip

SONIQUENCE, LLC

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

• Primary Device ID: 00810026180842
• NIH Device Record Key: 01c417d7-1465-4a3b-bc94-03946fbe24a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bipolar Forceps
• Version Model Number: SBF-011D-10
• Catalog Number: SBF-011D-10
• 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	00810026180842 [Package]; Contains: 00810026181344; Package: case [5 Units]; In Commercial Distribution
GS1	00810026181344 [Primary]

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 [Bipolar Forceps]

• 00810026181818: Bipolar Forceps reusable, Bayonet, 7 3/4", 1.0mm tip
• 00810026181801: Bipolar Forceps reusable, Bayonet, 6 1/2", 1.0mm tip
• 00810026181795: Bipolar Forceps reusable, Straight, 7 3/4", 1.0mm tip
• 00810026181788: Bipolar Forceps reusable, Jeweler #5, (Angled), 4 1/2", 0.5mm tip
• 00810026181771: Bipolar Forceps reusable, Jeweler #5, 4 1/2", 0.5mm tip
• 00810026181368: Bipolar Forceps sterile, Jeweler #5, (Angled), 4 1/2", 0.5mm tip
• 00810026180842: Bipolar Forceps sterile, Bayonet, 6 1/2", 1.0mm tip
• 00810026181184: Bipolar Forceps sterile, Jeweler #5, 4 1/2", 0.5mm tip
• 00810026181177: Bipolar Forceps sterile, Straight, 7 3/4", 1.0mm tip
• 00810026180200: Bipolar Forceps sterile, Bayonet, 7 3/4", 1.0mm tip