Prosthetic System

GUDID 08800000917818

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800000917818
NIH Device Record Key3a631000-c357-4727-877e-52361215fa59
Commercial Distribution StatusIn Commercial Distribution
Brand NameProsthetic System
Version Model NumberGSCAM23
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
GS108800000917818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800000917818]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-10-12

On-Brand Devices [Prosthetic System]

08800000963358HGZCA653SHW
08800000918037HGCVA401MP
08800000918020HGCVA401SP
08800000918013HGCVA402MP
08800000918006HGCVA402SP
08800000917993HGCVA403MP
08800000917986HGCVA403SP
08800000917979HGCVA404MP
08800000917962HGCVA404SP
08800000917955HGCVA481SP
08800000917948HGCVA482SP
08800000917931HGCVA483SP
08800000917924HGCVA484SP
08800000917917HGCVA485SP
08800000917900HGCVA601SP
08800000917894HGCVA602SP
08800000917887HGCVA603SP
08800000917870HGCVA604SP
08800000917863HGCVA605SP
08800000917856GSCAM01
08800000917849GSCAM01N
08800000917832GSCAM12
08800000917825GSCAM12N
08800000917818GSCAM23
08800000917801GSCAM23N
08800000917795GSCAS01
08800000917788GSCAS01N
08800000917771GSCAS12
08800000917764GSCAS12N
08800000917757GSCAS23
08800000917740GSCAS23N
08800000917733GSGA4510S
08800000917726GSGA4010B
08800000917719GSGA4010S
08800000917702GSGA4030B
08800000917696GSGA4030S
08800000917689GSGA4510B
08800000917672GSGA4530B
08800000917665GSGA4530S
08800000917658HGGCA401MHW
08800000917641HGGCA401MNW
08800000917634HGGCA403MHW
08800000917627HGGCA403MNW
08800000917610HGGCA451SHW
08800000917603HGGCA451SNW
08800000917597HGGCA453SHW
08800000917580HGGCA453SNW
08800000917573HGSAD351M
08800000917566HGSAD351S
08800000917559HGSAD352M

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