OSADA EXL-OSI2 3299

GUDID 04580406869877

OSADA ELECTRIC CO.,LTD.

Surgical power tool system control unit, line-powered
Primary Device ID04580406869877
NIH Device Record Key55981239-9a8a-4e9c-b985-737ebcabd191
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSADA EXL-OSI2
Version Model NumberEXL-OSI2
Catalog Number3299
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
GS104580406869877 [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 Date2018-07-09
Device Publish Date2018-06-07

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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