DEVICE: V files (04560264562967)

Device Identifier (DI) Information

V files
V-U15
In Commercial Distribution

NAKANISHI INC.
04560264562967
GS1

6
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

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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
Pneumatic dental scaling/debridement system handpiece tip, periodontal A sterile, removable endpiece intended to be attached to a pneumatic dental scaling/debridement system handpiece to apply sonic vibrational energy (e.g., at a frequency of 6 kHz) to fragment and dislodge accretions from tooth surfaces during dental cleaning/periodontal therapy; it is not intended for endodontic use. It is available in a variety of designs and may also be used for the removal of orthodontic cement. This is a reusable device after appropriate cleaning.
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FDA Product Code

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Product Code Product Code Name
ELC Scaler, ultrasonic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K991021 000
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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

4aff275c-a872-465c-af64-afb8419592d9
July 06, 2018
3
September 16, 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: 04560264565265 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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