FX Wrench

GUDID 04589551383986

NAKANISHI INC.

Dental surgical power tool motorized handpiece/set, electric
Primary Device ID04589551383986
NIH Device Record Key5e794098-ddea-49e7-a846-b9d976fdb679
Commercial Distribution StatusIn Commercial Distribution
Brand NameFX Wrench
Version Model NumberFX Wrench
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
GS104589551383986 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EGSHandpiece, contra- and right-angle attachment, dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-20
Device Publish Date2023-03-10

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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