SSH saggittal saw HP

Basic Information

• Brand Name: SSH saggittal saw HP
• Primary DI: 04582227427458
• Version / Model: SSH
• Catalog Number: 75418
• Company Name: OSADA ELECTRIC CO.,LTD.
• Labeler DUNS: 690713813
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 5
• Public Version Date: 2019-08-09
• Public Version Status: Update
• Public Device Record Key: 3ced3416-3292-4302-ac2b-5cc6e5bf100e

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
DZH	SAW, BONE, AC-POWERED	Dental	872.4120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52749	Surgical power tool system handpiece, sawing, line-powered	A hand-held, line-powered device (which may in addition include a rechargeable battery) that consists of a motorized saw handpiece intended to provide sagittal, oscillating, or reciprocating movement for attachable serrated blades designed to cut through hard/tough tissue during surgery. The device may be of the micro or macro design. It is powered from a control unit that supplies mains, stepped-down, low-voltage electricity (e.g., 24 volt) directly via an electrical connection cable. It is typically operated with a hand- or foot-switch. This is a reusable device.	No	Obsolete
43663	Sawing power tool attachment, sagittal	A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a sagittal sawing function when a sagittal saw blade is inserted. This attachment is designed with the cutting teeth arranged in an arc at the distal end pointing directly forward and cuts when the blade is powered in a rapid oscillating (side to side) movement. It is typically made of high-grade stainless steel and synthetic materials and is typically of the macro design. This is a reusable device.	No	Active
45573	Line-powered dental drilling/sawing system handpiece	A mains electricity (AC-powered), hand-held, dental device with a low-voltage electric motor (e.g., 24 volt) that provides power to a variety of attachable cutting endpieces for: 1) rotational motion (for drill bits, burs, and other rotary devices); and 2) reciprocal/oscillating motion for saw blades, as used in dental procedures to bore/excavate/saw bones, teeth, and tough tissues. It is typically connected via an electrical cord to a dental delivery system or a freestanding independent system. This is a reusable device.	No	Obsolete
38611	Dental power tool system handpiece, remotely-driven	A hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device does not incorporate a power source (e.g., an AC-powered motor). The rotational power is transferred from the power source to the endpiece via mechanical components (e.g., chains, gears, shafts) incorporated in the handpiece or via an external flexible drive system (e.g., a Bowden cable); the endpiece(s) are not included. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04582227427458	GS1

Premarket Submissions

Submission Number	Supplement Number
K935443	000