Bipolar Forceps SBF-004-10

GUDID 00810026181795

Bipolar Forceps reusable, Straight, 7 3/4", 1.0mm tip

SONIQUENCE, LLC

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 00810026181795
• NIH Device Record Key: eb2b5a0e-bbe8-48ef-906f-99ccbb9452fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bipolar Forceps
• Version Model Number: SBF-004-10
• Catalog Number: SBF-004-10
• 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: false
• Lot Batch: true
• Serial Number: false
• 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	00810026181795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964176

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00810026181795]

Moist Heat or Steam Sterilization

[00810026181795]

Moist Heat or Steam Sterilization

[00810026181795]

Moist Heat or Steam Sterilization

[00810026181795]

Moist Heat or Steam Sterilization

[00810026181795]

Moist Heat or Steam Sterilization

[00810026181795]

Moist Heat or Steam Sterilization

[00810026181795]

Moist Heat or Steam Sterilization

[00810026181795]

Moist Heat or Steam Sterilization

[00810026181795]

Moist Heat or Steam Sterilization

[00810026181795]

Moist Heat or Steam Sterilization

[00810026181795]

Moist Heat or Steam Sterilization

[00810026181795]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-08
• Device Publish Date: 2021-06-30

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