Osseofuse HexaPLUS Sinus Dental Implant

GUDID 00810044841169

OSSEOFUSE INTERNATIONAL, INC.

Dental implant abutment analog, laboratory
Primary Device ID00810044841169
NIH Device Record Keybdb32db5-1d63-44f0-9c47-1b95ec2c5976
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsseofuse HexaPLUS Sinus Dental Implant
Version Model NumberHTPA-NH
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
GS100810044841169 [Primary]

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810044841169]

Moist Heat or Steam Sterilization


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 Sinus Dental Implant]

00850005681601SLF5210
00850005681595SLF7510
00850005681588SLF6510
00850005681571SLF6508
00850005681564SLF7508
00850005681557SLF6510
00850005681540SLF6508
00850005681533SLF6508
00850005681526SLF7510
00850005681519SLF7508
00850005681502SLF6510
00850005681250SLF7510
00850005681243SLF7508
00850005681236SLF6510
00850005681229SLF6508
00850005681212SLF5211
00850005681205SLF5210
00850005681199SLF5208
00850005681182SLF4513
00850005681175SLF4511
00850005681168SLF4510
00850005681151SLF4508
00850005681144SLF7511
00850005681137SLF7510
00850005681120SLF7508
00850005681113SLF6511
00850005681106SLF6510
00850005681090SLF6508
00810044841381SLF4513
00810044841374SLF4511
00810044841367SLF4510
00810044841169HTPA-NH
00810044841152HTPA-H
00810044841145HGCA-NH
00810044841138HGCA-H
00810044841121HPCA-NH
00810044841114HPCA-H
00810044841107HOSA-RP
00810044841091HOSA-NP
00810044841084WCS-75
00810044841077WCS-65
00810044840353SLF7513
00810044840346SLF7511
00810044840339SLF7510
00810044840322SLF7508
00810044840315SLF6513
00810044840308SLF6511
00810044840292SLF6510
00810044840285SLF6508
00810044840278SLF5213

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