ENDO-MATE TC2

GUDID 04560264510647

NAKANISHI INC.

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Primary Device ID04560264510647
NIH Device Record Key6277c5f6-b424-4cfd-a1fb-7ac36b75dd2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDO-MATE TC2
Version Model NumberENDO-MATE TC2 Motor
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
GS104560264510647 [Primary]

FDA Product Code

EKXHandpiece, direct drive, ac-powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [ENDO-MATE TC2]

04560264510647ENDO-MATE TC2 Motor
04560264573284EMT2120VS
04560264573277EMT2120V1
04560264572874ENDO-MATE TC2 Motor

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