SP-Tip SST-T10

GUDID 00810026183669

SP-Tip

SONIQUENCE, LLC

Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: 00810026183669
• NIH Device Record Key: 485d014f-c1ca-4464-a046-a5eb9f12a4d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SP-Tip
• Version Model Number: SST-T10
• Catalog Number: SST-T10
• 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	00810026183652 [Primary]
GS1	00810026183669 [Package]; Contains: 00810026183652; Package: case [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183611

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: 2023-10-16
• Device Publish Date: 2023-10-06

On-Brand Devices [SP-Tip]

• 00810026181092: 10mm loop, 3cm shaft length
• 00810026181085: 6mm loop, 3cm shaft length
• 00810026181078: Spatula, 3cm shaft length
• 00810026181061: 5mm tip length, 3cm shaft length
• 00810026181054: 3mm ball, 3cm shaft length
• 00810026181047: 2mm ball, 3cm shaft length
• 00810026181030: 3mm loop, 3cm shaft length
• 00810026181023: Fine wire, 3cm shaft length
• 00810026180941: LLETZ Electrode With Hex Key
• 00810026180989: Multi-Glide Tip Electrode, Hex Key Adaptor (1 pc)
• 00810026180958: Broad Needle, Hex Key Adaptor (1 pc)
• 00810026181122: 1/8" Pin Electrode, Hex Key Adaptor (1 pc)
• 00810026180965: Assortment pack
• 00810026183669: SP-Tip