HS/HG Prosthetic System

GUDID 08800000915999

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800000915999
NIH Device Record Keye3e2a2b3-2b2d-4aed-a69f-cbbd1c5df3ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameHS/HG Prosthetic System
Version Model NumberHSSAD482R
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
GS108800000915999 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800000915999]

Moist Heat or Steam Sterilization


Device Entry Metadata

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

On-Brand Devices [HS/HG Prosthetic System]

08800000960678SSTCO602TH
08800000960661SSTCO600TH
08800000960654SSTCO482TH
08800000960647SSTCO480TH
08800000916743SSTAN480
08800000916736SSTAN482
08800000916729SSTAN600
08800000916712SSTAN602
08800000916705SSTAO480
08800000916699SSTAO482
08800000916682SSTAO600
08800000916675SSTAO602
08800000916668HSCTA480RNT
08800000916651HSCTA480ROT
08800000916644HSCTA482RNT
08800000916637HSCTA482ROT
08800000916620HSCTA600WNT
08800000916613HSCTA600WOT
08800000916606HSCTA602WNT
08800000916590HSCTA602WOT
08800000916583HSERC4804R
08800000916576HSERC4805R
08800000916569HSERC4807R
08800000916552HSERC6004W
08800000916545HSERC6005W
08800000916538HSERC6007W
08800000916521HGCTC4010HT
08800000916514HGCTC4010NT
08800000916507HGCTC4810ST
08800000916491HGCTC6010ST
08800000916484HGHLA6503S
08800000916477HGTFA8025SHW
08800000916460HGTFA8045SHW
08800000916453HSCAA4815ROW
08800000916446HSCAA4820ROW
08800000916439HSCAA6015WOW
08800000916422HSCAA6020WOW
08800000916415HSCOA4804RNW
08800000916408HSCOA4804ROW
08800000916392HSCOA4805RNW
08800000916385HSCOA4805ROW
08800000916378HSCOA4807RNW
08800000916361HSCOA4807ROW
08800000916354HSCOA6004WNW
08800000916347HSCOA6004WOW
08800000916330HSCOA6005WNW
08800000916323HSCOA6005WOW
08800000916316HSCOA6007WNW
08800000916309HSCOA6007WOW
08800000916293SSCA607

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