Bipolar Cable SBCD-FP/1

GUDID 00810026181528

Flat Prong Plug Bipolar Cable, Sterile/Disposable

SONIQUENCE, LLC

Electrical-only medical device connection cable, single-use

• Primary Device ID: 00810026181528
• NIH Device Record Key: a415f717-47d1-439c-b147-b7109253dafd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bipolar Cable
• Version Model Number: SBCD-FP/1
• Catalog Number: SBCD-FP/1
• 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	00810026181528 [Package]; Contains: 00810026181764; Package: case [10 Units]; In Commercial Distribution
GS1	00810026181764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190336

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: 2021-04-06
• Device Publish Date: 2021-03-29

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• 00810026181511: Bipolar Cable, Sterile/Disposable
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• 00810026180507: IEC Bipolar Cord, Reusable