TRAUS ENDO

GUDID 08809260470231

Control Box

Saeshin Precision Co., Ltd.

Dental power tool system, line-powered
Primary Device ID08809260470231
NIH Device Record Key79a06fa5-5c63-4f47-a46c-2b03065ef23f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRAUS ENDO
Version Model NumberTRAUS MCE10XX
Company DUNS688019566
Company NameSaeshin Precision Co., Ltd.
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809260470231 [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 Date2020-01-30
Device Publish Date2020-01-22

On-Brand Devices [TRAUS ENDO]

08809260470774'10:1 TRAUS MCE10XX+TRAUS XEW10+ACL(B)-46EP
08809260470767'16:1 TRAUS MCE10XX+TRAUS XEW10+ACL(B)-42EP
0880926047074320:1 TRAUS MCE10XX+TRAUS XEW10+ACL(B)-41EP
08809260470262Angle Handpiece
08809260470255Angle Handpiece
08809260470248Charger
08809260470231Control Box

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