CH17 contra head 70049

GUDID 04582227341594

OSADA ELECTRIC CO.,LTD.

Line-powered dental drilling/sawing system handpiece
Primary Device ID04582227341594
NIH Device Record Key5b78c7d3-f8e8-413f-8dd8-e1d48effc1cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCH17 contra head
Version Model NumberCH17
Catalog Number70049
Company DUNS690713813
Company NameOSADA ELECTRIC CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS104582227341594 [Primary]

FDA Product Code

EKXHANDPIECE, DIRECT DRIVE, AC-POWERED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04582227341594]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-22
Device Publish Date2016-09-29

Devices Manufactured by OSADA ELECTRIC CO.,LTD.

04582227353498 - ST452020-03-27
04580406860690 - ST38-90R2019-02-21
04580406860706 - ST38-90L2019-02-21
04580406860713 - ST38-902019-02-21
04580406860720 - AP set 72019-02-21
04580406860737 - AP point 12019-02-21
04580406860744 - AP point 22019-02-21
04580406860751 - AP point 32019-02-21

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