CH11B contra head 40098

GUDID 04582227341587

OSADA ELECTRIC CO.,LTD.

Line-powered dental drilling/sawing system handpiece
Primary Device ID04582227341587
NIH Device Record Key46eb590f-563d-4dd4-bd8e-b27503e78716
Commercial Distribution StatusIn Commercial Distribution
Brand NameCH11B contra head
Version Model NumberCH11B
Catalog Number40098
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
GS104582227341587 [Primary]

FDA Product Code

EKXHANDPIECE, DIRECT DRIVE, AC-POWERED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04582227341587]

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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