DEVICE: SH28S/LVS/MCC6 assy. (04582227407290)

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Device Identifier (DI) Information

SH28S/LVS/MCC6 assy.
SH28S/LVS/MCC6
51751
OSADA ELECTRIC CO.,LTD.
04582227407290
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental power tool system handpiece, remotely-driven A hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drills, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device is remote from the power source (an AC-powered motor) and is connected by a flexible drive system (e.g., a Bowden cable) that transfers the rotational power; the endpiece(s) are not included. This is a reusable device.
Remotely-driven dental drilling system motor A mains electricity (AC-powered) compact motor used in conjunction with a spinning cable (e.g., a Bowden cable) to provide remote rotational power from the motor to a dental drill handpiece. This device is line-powered and cannot be sterilized. This is a reusable device.
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 instruments for: 1) rotational motion (for drills, 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.
Remotely-driven surgical/dental system drive cable A flexible device for transmitting rotational power from a remote surgical or dental drilling system motor/control unit to the drilling handpiece. The drive is designed so that the handpiece can be flexibly manipulated by the operator (the surgeon or dentist). The design is typically based on a rotating metal spun spiral cable within a protective sheath; this is commonly known as a Bowden cable. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
EKX HANDPIECE, DIRECT DRIVE, AC-POWERED
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Sterilization

No
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 29, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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