DEVICE: SOH oscillating saw HP (04582227341464)

Device Identifier (DI) Information

SOH oscillating saw HP
SOH
In Commercial Distribution
75686
OSADA ELECTRIC CO.,LTD.
04582227341464
GS1

1
690713813 *Terms of Use
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Obsolete false
43665 Sawing power tool attachment, oscillating
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 an oscillating sawing function when an oscillating saw blade is inserted. This attachment is designed with the cutting teeth arranged in an arc or on a flat plane at its distal end; the teeth are at a 90° angle to its shaft and it cuts when it is moved in a rapid oscillating motion. It is typically made of high-grade stainless steel and synthetic materials and of the macro design. This is a reusable device.
Active false
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.
Obsolete false
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.
Obsolete false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DZH SAW, BONE, AC-POWERED
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K935443 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

9f3c0fab-89bf-40c4-bc1d-c740ba499594
August 09, 2019
5
September 20, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE