DEVICE: SE-05 handpiece (04582227341822)

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Device Identifier (DI) Information

SE-05 handpiece
SE-05
72308
OSADA ELECTRIC CO.,LTD.
04582227341822
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 ultrasonic surgical system handpiece A hand-held component of a dental ultrasonic surgical system that typically converts high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and cut bone upon contact during dental surgery. The operator regulates the energy with an electric power switch incorporated into a foot-pedal that is attached to the generator. The handpiece typically includes cables and tubing, and may serve as a conduit for irrigation to the site of intervention. This is a reusable device.
Ultrasonic dental scaling/debridement system handpiece A hand-held component of an ultrasonic dental debridement system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form of a pen/pencil with attached cables. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
ELC Scaler, ultrasonic
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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 20, 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
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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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