Endo A Class

GUDID 08809394971345

SAEYANG MICROTECH CO.,LTD

Dental power tool system handpiece, line-powered
Primary Device ID08809394971345
NIH Device Record Keye0ede043-be70-4778-b2fe-5e741c74ceb9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo A Class
Version Model NumberEndo A Class
Company DUNS631078094
Company NameSAEYANG MICROTECH 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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809394971345 [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 Date2020-10-01
Device Publish Date2020-09-23

Devices Manufactured by SAEYANG MICROTECH CO.,LTD

08809394971352 - PRO M CLASS2023-06-15 The PRO M CLASS is an AC-powered device that includes a "Motor Handpiece","Contra angle Handpiece","Charger unit" and "AC/DC Ada
08809394970881 - Ki-202020-10-01
08809394970997 - Endo E Class2020-10-01
08809394971345 - Endo A Class 2020-10-01
08809394971345 - Endo A Class 2020-10-01

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