SMTP

GUDID 06972603519194

Trephine (300mm, 3.6mm)

SMTP Medical Co., Ltd.

Hard-tissue ultrasonic surgical system handpiece tip

• Primary Device ID: 06972603519194
• NIH Device Record Key: 5dbc8323-eb54-4e8f-9824-e63ee3321b12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMTP
• Version Model Number: XDF02812533
• Company DUNS: 554428394
• Company Name: SMTP Medical Co., Ltd.
• 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: true
• 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	06972603519194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201274

FDA Product Code

• JDX: Instrument, Surgical, Sonic And Accessory/Attachment

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: 2023-08-23
• Device Publish Date: 2023-08-15

On-Brand Devices [SMTP]

• 06972603519200: 300mm,3.6mm
• 06972603519194: Trephine (300mm, 3.6mm)
• 06972603519187: Hook-shaped scalpel with serrations (140mm)
• 06972603519170: Hook-shaped scalpel with serrations (80mm)
• 06972603519163: Spiral shaped scalpel (300mm, 4.2mm)
• 06972603519156: Spiral shaped scalpel (300mm, 3.6mm)
• 06972603519149: V-shaped scalpel (140mm)
• 06972603519132: V-shaped scalpel (80mm)
• 06972603519125: Curette with teeth (140mm)
• 06972603519118: Curette with teeth (80mm)
• 06972603519101: Bilateral scalpel with serrations (300mm, 3.6mm)
• 06972603519095: Bilateral scalpel with serrations (140mm,Curved)
• 06972603519088: Bilateral scalpel with serrations (140mm)
• 06972603519071: Bilateral scalpel with serrations (80mm)
• 06972603519057: Torque wrench
• 06972603519040: Liquid-flow sleeve (hard)
• 06972603519033: Liquid-flow tube
• 06972603519026: Handpiece
• 06972603519019: Double-key Foot switch
• 06972603519002: SMTP Ultrasonic Osteotomy Surgical System
• 06927292311475: Spiral shaped scalpel (80mm)
• 06972603519064: Sterilization box (MIS)
• 06972603519217: Sterilization box
• 06972603519231: Spherical scalpel (140mm)
• 06972603519224: Spherical scalpel (80mm)