GS System

GUDID 08800000908748

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800000908748
NIH Device Record Key43fd7f4d-017d-4e0e-9fd8-3ff78752a6ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameGS System
Version Model NumberGSSAM3540O
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
GS108800000908748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800000908748]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-10-02

On-Brand Devices [GS System]

08800000957845GSASR
08800000909547GSRPC440
08800000909530GSRPC460
08800000909523GSRPC470
08800000909516GSRPC540
08800000909509GSRPC560
08800000909493GSRPC570
08800000909486GSRPC640
08800000909479GSRPC660
08800000909462GSRPC670
08800000909455GSTA5611
08800000909448GSTA5621
08800000909431GSTA5631
08800000909424GSTA5641
08800000909417GSTA5611N
08800000909400GSTA5621N
08800000909394GSTA5631N
08800000909387GSTA5641N
08800000909370GS25FA4015N
08800000909363GS25FA4015
08800000909356GS25FA4030N
08800000909349GS25FA4030
08800000909332GS25FA5515N
08800000909325GS25FA5515
08800000909318GS25FA5530N
08800000909301GS25FA5530
08800000909295GS25FA7015N
08800000909288GS25FA7015
08800000909271GS25FA7030N
08800000909264GS25FA7030
08800000909257GSFA4015
08800000909240GSFA4015N
08800000909233GSFA4030
08800000909226GSFA4030N
08800000909219GSFA5515
08800000909202GSFA5515N
08800000909196GSFA5530
08800000909189GSFA5530N
08800000909172GSFA7015
08800000909165GSFA7015N
08800000909158GSFA7030
08800000909141GSFA7030N
08800000909134GSFAM4015
08800000909127GSFAM4015N
08800000909110GSFAM4030
08800000909103GSFAM4030N
08800000909097GSAA4320A
08800000909080GSAA4320B
08800000909073GSAA4320N
08800000909066GSAA4340A

Trademark Results [GS System]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GS SYSTEM
GS SYSTEM
79203538 5388853 Live/Registered
Lonza Ltd.
2016-11-21

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