DEVICE: Ti-Max X (04560264510906)

Device Identifier (DI) Information

Ti-Max X
X55
Not in Commercial Distribution

NAKANISHI INC.
04560264510906
GS1
February 15, 2021
1
690710546 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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?
45574 Dental power tool converter attachment, non-rotary
A dental attachment, commonly known as a ratchet adaptor, drive converter, or dental turbine, designed to be fitted in a dental power tool handpiece to convert energy (e.g., electrical, pneumatic) to a sagittal, oscillating or reciprocating mechanical motion to achieve a specific function (e.g., sawing) during dental procedures [e.g., maxillofacial surgery]. It is not an endpiece; an appropriate interchangeable endpiece (e.g., saw blade) is intended to be fixed to the working end of this device. This is a reusable device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
EGS Handpiece, contra- and right-angle attachment, dental
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
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 Record Status

5f18a8c3-227e-41ef-82f6-f25db32f97d3
February 15, 2021
3
June 05, 2020
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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)

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

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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