SC point 4-17 50076

GUDID 04582227379849

OSADA ELECTRIC CO.,LTD.

Ultrasonic dental scaling/debridement system handpiece tip, endodontic
Primary Device ID04582227379849
NIH Device Record Key4d4fdad3-27a9-46c2-ba7d-d02b1111c15a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSC point 4-17
Version Model NumberSC point 4-17
Catalog Number50076
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 Batchtrue
Serial Numberfalse
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
GS104582227379849 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04582227379849]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-21
Device Publish Date2016-09-20

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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