SMTP

Basic Information

• Brand Name: SMTP
• Primary DI: 06972603519002
• Version / Model: XD880A
• Company Name: SMTP Medical Co., Ltd.
• Labeler DUNS: 554428394
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-15
• Public Version: 2
• Public Version Date: 2023-10-09
• Public Version Status: Update
• Public Device Record Key: 8ea720a7-1dfd-4fdc-a46f-8560e15d96d1

Device Description

SMTP Ultrasonic Osteotomy Surgical System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JDX	Instrument, Surgical, Sonic And Accessory/Attachment	Orthopedic	888.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36273	Ultrasonic surgical system generator	An electrically-powered component of an ultrasonic surgical system intended to generate a high frequency electrical current that is converted, typically within a handpiece, into an ultrasonic oscillation to fragment hard and/or soft tissue cells upon contact with a vibrating tip. It is used in a variety of surgical disciplines (e.g., arthroscopy, gynaecology, neurosurgery, dental/craniomaxillofacial reconstructive surgery); it is not dedicated to dental applications. It provides the controls and monitoring functions for the system during the procedure, and typically regulates energy to the system via a foot-switch; integrated suction/aspiration function may be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06972603519002	GS1