HS II Fixture Mini RBM Pre-Mounted

GUDID 00814913022741

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00814913022741
NIH Device Record Keybfc2a8c7-a22e-45ef-94c0-475769e8cfc5
Commercial Distribution StatusIn Commercial Distribution
Brand NameHS II Fixture Mini RBM Pre-Mounted
Version Model NumberAHS2M3515R28
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
GS100814913022741 [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 Date2015-09-08

On-Brand Devices [HS II Fixture Mini RBM Pre-Mounted]

00814913022741AHS2M3515R28
00814913022734AHS2M3515R18
00814913022703AHS2M3511R28

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