SP-Kit SSP-01

GUDID 00810026181016

Fingerswitch Wand & 4 SP-Tips

SONIQUENCE, LLC

Electrosurgical handpiece, single-use

• Primary Device ID: 00810026181016
• NIH Device Record Key: 9ca34e7e-ce73-412e-95c8-96e3e50d51dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SP-Kit
• Version Model Number: SSP-01
• Catalog Number: SSP-01
• 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	00810026181016 [Primary]

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: 2021-01-22
• Device Publish Date: 2021-01-14

Devices Manufactured by SONIQUENCE, LLC

• 00810026183782 - SP-Tip: 2025-07-28 SP-Tip, Microwire, 0.1mm tip
• 00810026183669 - SP-Tip: 2023-10-16 SP-Tip
• 00810026183706 - Soni-Cerv: 2023-10-16 LEEP Ball electrode
• 00810026183775 - Bleph kit: 2023-10-16 Bleph Kit
• 00810026180248 - Blepharoplasty kit: 2023-04-04 Blepharoplasty Kit
• 00810026180972 - Reusable Handpiece: 2023-04-04 Reusable Handpiece
• 00810026181535 - RF Generator: 2023-04-04 RF Generator
• 00810026181542 - RF Generator: 2023-04-04 RF Generator