Microincision Tip STEE328

GUDID 00810026180583

Microincision Tip, 2.5cm shaft length, Curved, 1 pc.

SONIQUENCE, LLC

Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: 00810026180583
• NIH Device Record Key: fb62cd61-da73-49d6-93e1-24fe3115a493
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microincision Tip
• Version Model Number: STEE328
• Catalog Number: STEE328
• 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	00810026180583 [Primary]
GS1	00810026181924 [Package]; Package: case [2 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-04-02
• Device Publish Date: 2020-05-19

On-Brand Devices [Microincision Tip]

• 00810026180583: Microincision Tip, 2.5cm shaft length, Curved, 1 pc.
• 00810026180354: Microincision Tip, 3cm shaft length, 45 degree angle, 1 pc.
• 00810026180316: Microincision Tip, 3cm shaft length, straight, 1 pc.
• 00810026180231: Microincision Tip, 3cm shaft length, 45 degree angle, 2 pc.