Reusable Handpiece SIEC-3FHPB/NS

GUDID 00810026180972

Reusable Handpiece

SONIQUENCE, LLC

Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable

• Primary Device ID: 00810026180972
• NIH Device Record Key: 2bae2b05-48ee-40ac-af4d-1e4826226ae9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Handpiece
• Version Model Number: SIEC-3FHPB/NS
• Catalog Number: SIEC-3FHPB/NS
• 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	00810026180972 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212222

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00810026180972]

Hydrogen Peroxide

[00810026180972]

Hydrogen Peroxide

[00810026180972]

Hydrogen Peroxide

[00810026180972]

Hydrogen Peroxide

[00810026180972]

Hydrogen Peroxide

[00810026180972]

Hydrogen Peroxide

[00810026180972]

Hydrogen Peroxide

[00810026180972]

Hydrogen Peroxide

[00810026180972]

Hydrogen Peroxide

[00810026180972]

Hydrogen Peroxide

[00810026180972]

Hydrogen Peroxide

[00810026180972]

Hydrogen Peroxide

[00810026180972]

Hydrogen Peroxide

[00810026180972]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-04-04
• Device Publish Date: 2022-12-30

Devices Manufactured by SONIQUENCE, LLC

• 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: 2023-04-04Reusable Handpiece
• 00810026180972 - Reusable Handpiece: 2023-04-04 Reusable Handpiece
• 00810026181535 - RF Generator: 2023-04-04 RF Generator
• 00810026181542 - RF Generator: 2023-04-04 RF Generator
• 00810026181559 - RF Generator: 2023-04-04 RF Generator