Osseofuse OnePLUS Dental Implant

GUDID 00810044840377

OSSEOFUSE INTERNATIONAL, INC.

Dental implant system
Primary Device ID00810044840377
NIH Device Record Key9a9cccf0-c382-455e-938a-f7cd7571fe95
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsseofuse OnePLUS Dental Implant
Version Model NumberOPF3013
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
GS100810044840377 [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 OnePLUS Dental Implant]

00810044840476OPF5214
00810044840469OPF5213
00810044840452OPF5211
00810044840445OPF4514
00810044840438OPF4513
00810044840421OPF4511
00810044840414OPF3714
00810044840407OPF3713
00810044840391OPF3711
00810044840384OPF3014
00810044840377OPF3013
00810044840360OPF3011
00858249007478OPF3010
00854989008355OPF4510
00854989008294OPF3710
00810044841404OPF3008
00810044841398OPF5210

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