HG II Fixture RBM Mini No Mount

GUDID 00814913021560

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00814913021560
NIH Device Record Key58e055a5-fd61-4d5f-a8cb-ea85ef488d76
Commercial Distribution StatusIn Commercial Distribution
Brand NameHG II Fixture RBM Mini No Mount
Version Model NumberCHG2M3515R
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
GS100814913021560 [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 Mini No Mount]

00814913021560CHG2M3515R
00814913021553CHG2M3513R
00814913021546CHG2M3511R
00814913021539CHG2M3510R
00814913021522CHG2M3508R

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