US/SS/GS System

GUDID 08800000902319

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800000902319
NIH Device Record Keyd307fcf4-bfba-4ba9-b19b-fcccbbe44ccb
Commercial Distribution StatusIn Commercial Distribution
Brand NameUS/SS/GS System
Version Model NumberGSRA6750P
Company DUNS689051793
Company NameOsstem Implant 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 Usetrue
Lot Batchtrue
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
GS108800000902319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800000902319]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-09-24

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08800000907673CAR514N
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08800000907659CAR514NWH
08800000907642CAR514TH
08800000907635CAR514WH
08800000907628CAR515
08800000907611CAR515N
08800000907604CAR515NTH
08800000907598CAR515NWH
08800000907581CAR515TH
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08800000907567CAR517
08800000907550CAR517N
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08800000907536CAR517NWH
08800000907529CAR517TH
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08800000907505CAR524
08800000907499CAR524N
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08800000907475CAR524NWH
08800000907468CAR524TH
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08800000907444CAR525
08800000907437CAR525N
08800000907420CAR525NTH
08800000907413CAR525NWH
08800000907406CAR525TH
08800000907390CAR525WH
08800000907383CAR527
08800000907376CAR527N

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