Hiossen Prosthetic System

GUDID 08800000925394

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800000925394
NIH Device Record Keyb27c66f7-3490-40cc-9bad-03942a501787
Commercial Distribution StatusIn Commercial Distribution
Brand NameHiossen Prosthetic System
Version Model NumberMGR200TH
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
GS108800000925394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800000925394]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-10-16

On-Brand Devices [Hiossen Prosthetic System]

08800000963327OAON01S
08800000925608ETHLAP5M
08800000925592ETHLAP7M
08800000925585ETHLAP9M
08800000925578ETHLAP5R
08800000925561ETHLAP7R
08800000925554ETHLAP9R
08800000925547GSCHABSMT
08800000925530GSCHABSST
08800000925523HGNCA401MHW
08800000925516HGNCA403MHW
08800000925509HGNCA401MNW
08800000925493HGNCA403MNW
08800000925486HGNCA451SHW
08800000925479HGNCA453SHW
08800000925462HGNCA451SNW
08800000925455HGNCA453SNW
08800000925448ORN1C
08800000925431ORN1R
08800000925424ORN1
08800000925417MGR100TH
08800000925400MGW100TH
08800000925394MGR200TH
08800000925387MGW200TH
08809892359041MGW200TH
08809892359027MGW100TH
08809892359003MGR200TH
08809892358983MGR100TH

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