X450 M4

GUDID 04560264572645

NAKANISHI INC.

Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic
Primary Device ID04560264572645
NIH Device Record Key985e6bf6-748b-4e6e-9596-06c8e96eb02f
Commercial Distribution StatusIn Commercial Distribution
Brand NameX450 M4
Version Model NumberX450 M4
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 Numbertrue
Manufacturing Datefalse
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
GS104560264533523 [Direct Marking]
GS104560264572645 [Primary]

FDA Product Code

EFBHandpiece, air-powered, dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


[04560264572645]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-29
Device Publish Date2020-07-21

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04589551355037 - P300-2A202023-11-21
04589551355129 - P300-2A402023-11-21
04589551355136 - P300-2A602023-11-21
04589551355228 - P300-2A802023-11-21
04589551355235 - P300-2S102023-11-21

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