SonoSurg Curved Scissors,Pistol Grip,5mm x 45cm

Basic Information

• Brand Name: SonoSurg Curved Scissors,Pistol Grip,5mm x 45cm
• Primary DI: 04953170235641
• Version / Model: T3795
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-06
• Public Version: 8
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: 884d6e90-98c6-4262-b37d-2d4c74606616
• Distribution End Date: 2022-08-12

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
64417	Soft-tissue ultrasonic surgical system holder/tip, reusable	A hand-held component of an ultrasonic surgical system which includes a holder with controls and a surgical endpiece (tip) intended to be connected to a system transducer (not included) whereby the tip oscillates (vibrates) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating soft tissue during surgery. It may be referred to as a handpiece but does not include a transducer; the tip is available in a variety of forms and sizes, is typically made of metal, and may include a disposable tube to cover the shaft of the tip. This device is utilized in a variety of surgical disciplines. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14953170235648	GS1		1	Not in Commercial Distribution	2022-08-12
Primary	04953170235641	GS1

Customer Contacts

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