SonoSurg Transducer

Basic Information

• Brand Name: SonoSurg Transducer
• Primary DI: 04953170142628
• Version / Model: SonoSurg-T2H-C
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-06
• Public Version: 7
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: c9411b8d-6b7b-4654-91fb-3402d2423b31

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LFL	Instrument, ultrasonic surgical	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
61846	Ultrasonic surgical system transducer	A hand-held component of an ultrasonic surgical system intended to be connected to a system holder/tip or combined holder/tip, whereby it is designed to convert high frequency electrical current from a generator into an ultrasonic oscillation, to fragment hard and/or soft tissue cells for cutting and/or coagulating tissue during surgery (e.g., arthroscopic); it is not dedicated to dental applications. It may be referred to as a handpiece however it does not include controls and cannot be directly connected to the tip. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14953170142625	GS1		1	In Commercial Distribution
Primary	04953170142628	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]