HG II Fixture RBM Regular No Mount

GUDID 00814913021706

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00814913021706
NIH Device Record Keyb91dd609-d059-4c17-bd30-36a29957c22c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHG II Fixture RBM Regular No Mount
Version Model NumberCHG2S5008R
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
GS100814913021706 [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 Fixture RBM Regular No Mount]

00814913021744CHG2S5015R
00814913021737CHG2S5013R
00814913021720CHG2S5011R
00814913021713CHG2S5010R
00814913021706CHG2S5008R
00814913021690CHG2S5007R
00814913021683CHG2S4515R
00814913021676CHG2S4513R
00814913021669CHG2S4511R
00814913021652CHG2S4510R
00814913021645CHG2S4508R
00814913021638CHG2S4507R
00814913021621CHG2S4015R
00814913021614CHG2S4013R
00814913021607CHG2S4011R
00814913021591CHG2S4010R
00814913021584CHG2S4008R
00814913021577CHG2S4007R

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