OSADA ENDEX-XV 5057

GUDID 04580406860133

OSADA ELECTRIC CO.,LTD.

Endodontic apex locator
Primary Device ID04580406860133
NIH Device Record Key67d7b7a3-cd25-4170-9e30-4a71d02bdffc
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSADA ENDEX-XV
Version Model NumberOSADA ENDEX-XV
Catalog Number5057
Company DUNS690713813
Company NameOSADA ELECTRIC 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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104580406860133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LQYLocator, root apex

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-20
Device Publish Date2018-11-19

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.