HG II Ultra-Wide Fixture

GUDID 00814913021843

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00814913021843
NIH Device Record Key1374fb31-9c66-415d-b61b-022f906d869a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHG II Ultra-Wide Fixture
Version Model NumberCHG2S7013R
Company DUNS796083090
Company NameHIOSSEN, INC.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814913021843 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-02

On-Brand Devices [HG II Ultra-Wide Fixture]

00814913021843CHG2S7013R
00814913021836CHG2S7011R
00814913021829CHG2S7010R
00814913021812CHG2S7008R
00814913021805CHG2S7007R
00814913021799CHG2S6013R
00814913021782CHG2S6011R
00814913021775CHG2S6010R
00814913021768CHG2S6008R
00814913021751CHG2S6007R

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