OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS

GUDID 08800000995830

Osstem Implant Co.,Ltd.

Dental amalgam mixer
Primary Device ID08800000995830
NIH Device Record Keyf8b1f94b-9182-4b53-ba84-e5a8a68a447a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
Version Model NumberHYMIX
Company DUNS695235881
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800000995830 [Primary]

FDA Product Code

EFDAmalgamator, Dental, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-08
Device Publish Date2022-10-31

On-Brand Devices [OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS]

08800000995724A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed
08800000995052A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed
08800000995045A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed
08800000995830HYMIX

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