US/GS Ultra Wide System

GUDID 08800000900339

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800000900339
NIH Device Record Key6912e227-1650-4951-a599-bd84c3cc6052
Commercial Distribution StatusIn Commercial Distribution
Brand NameUS/GS Ultra Wide System
Version Model NumberGSHAS753
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800000900339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-09-23

On-Brand Devices [US/GS Ultra Wide System]

08800000900414AIHW803
08800000900407AIHW805
08800000900391CAW825
08800000900384CAW825TH
08800000900377CAW825WH
08800000900360CAW845
08800000900353CAW845TH
08800000900346CAW845WH
08800000900339GSHAS753
08800000900322GSHAS755
08800000900315GSHAS757
08800000900308GSRA7610P
08800000900292GSRA7620P
08800000900285GSRA7630P
08800000900278GSRA7640P
08800000900261GSRA7650P
08800000900254GSRA8620
08800000900247GSRA8620P
08800000900230GSRA8640
08800000900223GSRA8640P
08800000900216GSRPC760
08800000900209GSRPC860
08800000900193GSTA7610NWH
08800000900186GSTA7610WH
08800000900179GSTA7620NWH
08800000900162GSTA7620WH
08800000900155GSTA7630NWH
08800000900148GSTA7630WH
08800000900131GSTA7640NWH
08800000900124GSTA7640WH
08800000900117GSTA7650NWH
08800000900100GSTA7650WH
08800000900094GSTA8620
08800000900087GSTA8620WH
08800000900070GSTA8640
08800000900063GSTA8640WH

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