EH MONO

GUDID 07290112440334

Harmony One-Piece Dental Implant

ETGAR - MEDICAL INSTRUMENTS LTD

Screw endosteal dental implant, two-piece
Primary Device ID07290112440334
NIH Device Record Keyfc3a3625-962c-4c75-a5e1-d9e781a9c219
Commercial Distribution StatusIn Commercial Distribution
Brand NameEH MONO
Version Model NumberEH-3.6-L11.5
Company DUNS514570324
Company NameETGAR - MEDICAL INSTRUMENTS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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
GS107290112440334 [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 Date2018-02-26

On-Brand Devices [EH MONO]

07290112440396Harmony One-Piece Dental Implant
07290112440389Harmony One-Piece Dental Implant
07290112440372Harmony One-Piece Dental Implant
07290112440365Harmony One-Piece Dental Implant
07290112440358Harmony One-Piece Dental Implant
07290112440341Harmony One-Piece Dental Implant
07290112440334Harmony One-Piece Dental Implant
07290112440327Harmony One-Piece Dental Implant
07290112440310Harmony One-Piece Dental Implant
07290112440303Harmony One-Piece Dental Implant
07290112440297Harmony One-Piece Dental Implant
07290112440280Harmony One-Piece Dental Implant

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