Osseofuse HexaPLUS Dental Implant

GUDID 00810044840094

OSSEOFUSE INTERNATIONAL, INC.

Dental implant system
Primary Device ID00810044840094
NIH Device Record Keyece77ece-0455-4c8c-8e1f-0a2596a7ccfb
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsseofuse HexaPLUS Dental Implant
Version Model NumberHPF4113
Company DUNS080694564
Company NameOSSEOFUSE INTERNATIONAL, 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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810044840094 [Primary]

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-12
Device Publish Date2020-03-04

On-Brand Devices [Osseofuse HexaPLUS Dental Implant]

00850005681625HPF4511
00850005681618HPF4510
00850005681496HPF5214
00850005681489HPF5213
00850005681472HPF5211
00850005681465HPF5210
00850005681458HPF5210
00850005681441HPF5208
00850005681434HPF5208
00850005681427HPF4514
00850005681410HPF4513
00850005681403HPF4510
00850005681397HPF4508
00850005681380HPF4508
00850005681373HPF4508
00850005681366HPF4508
00850005681359HPF3716
00850005681342HPF3714
00850005681335HPF3713
00850005681328HPF3713
00850005681311HPF3713
00850005681304HPF3713
00850005681298HPF3711
00850005681281HPF3711
00850005681274HPF3710
00850005681267HPF4514
00850005681083HPF5214
00850005681076HPF5213
00850005681069HPF5211
00850005681052HPF5210
00850005681045HPF5208
00850005681038HPF4514
00850005681021HPF4513
00850005681014HPF4511
00850005681007HPF4510
00810044841053HPAS
00810044841046HBA-OD
00810044841022HTTA-H
00810044841015HAA-17
00810044841008HSA-S
00810044840995HFCA-HL
00810044840988HFCA-LL
00810044840971HFCA-HS
00810044840964HFCA-LS
00810044840957HOSA-L
00810044840940HOSA-R
00810044840933HOSA-S
00810044840926HPHA5307
00810044840919HPHA5305
00810044840902HPHA5303

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.