Reusable Neutral Plate SIEC-NP

GUDID 00810026180910

Reusable Neutral Plate

SONIQUENCE, LLC

Electrosurgical return electrode, reusable

• Primary Device ID: 00810026180910
• NIH Device Record Key: bbc86f30-3767-4b57-b0f8-c334af596a99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Neutral Plate
• Version Model Number: SIEC-NP
• Catalog Number: SIEC-NP
• 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	00810026180910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220071

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-08
• Device Publish Date: 2022-02-28

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• 00810026181535 - RF Generator: 2023-04-04 RF Generator
• 00810026181542 - RF Generator: 2023-04-04 RF Generator
• 00810026181559 - RF Generator: 2023-04-04 RF Generator