DEVICE: SH29S (04582227411860)

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Device Identifier (DI) Information

SH29S
SH29S
70100
OSADA ELECTRIC CO.,LTD.
04582227411860
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.
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.
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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

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Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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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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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