OneJet SG

GUDID 08809917147431

Osstem Implant Co.,Ltd.

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Primary Device ID08809917147431
NIH Device Record Key9ac71453-e249-4a15-bea6-fdeb66bf42c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneJet SG
Version Model NumberOJSG-500
Company DUNS963215286
Company NameOsstem Implant 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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809917147431 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-05
Device Publish Date2024-06-27

On-Brand Devices [OneJet SG]

08809917147448OJSG
08809917147431OJSG-500

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