DEVICE: OSADA ENDEX (04580406860348)

Device Identifier (DI) Information

OSADA ENDEX
EM-S2
In Commercial Distribution
5032
OSADA ELECTRIC CO.,LTD.
04580406860348
GS1

1
690713813 *Terms of Use
No description.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Endodontic apex locator A dental instrument, using electricity, designed to locate the top of the root canal during endodontic procedures. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
LQY Locator, root apex
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K904742 000
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

4d670dde-8b33-4629-8349-e68c648ffc64
July 06, 2018
3
September 20, 2016
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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
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Secondary DI

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

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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