SX-SU05

GUDID 04560264513044

NAKANISHI INC.

Dental surgical power tool motorized handpiece/set, pneumatic
Primary Device ID04560264513044
NIH Device Record Key064ecf1a-1d44-4cd1-8f4a-82c09d965a2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSX-SU05
Version Model NumberSX-SU05
Company DUNS690710546
Company NameNAKANISHI INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104560264513044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFBHandpiece, air-powered, dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-02
Device Publish Date2022-10-25

Devices Manufactured by NAKANISHI INC.

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04560264502963 - PTL Nozzle2024-11-11
04560264502970 - EZ-M4 Adaptor2024-11-11
04589551392063 - EZ SPRAY2024-11-11
04589551391950 - M2052024-10-24
04560264578586 - FX204 M42024-10-24
04589551389391 - Surgic Pro2 OPT2024-10-23

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