OnePLUS Dental Implant

GUDID 00810044842883

OSSEOFUSE INTERNATIONAL, INC.

Surgical screwdriver, reusable
Primary Device ID00810044842883
NIH Device Record Key571e35e4-cfbd-46be-a709-85ae1298fb46
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnePLUS Dental Implant
Version Model NumberOPID-M-L
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810044842883 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810044842883]

Moist Heat or Steam Sterilization


[00810044842883]

Moist Heat or Steam Sterilization


[00810044842883]

Moist Heat or Steam Sterilization


[00810044842883]

Moist Heat or Steam Sterilization


[00810044842883]

Moist Heat or Steam Sterilization


[00810044842883]

Moist Heat or Steam Sterilization


[00810044842883]

Moist Heat or Steam Sterilization


[00810044842883]

Moist Heat or Steam Sterilization


[00810044842883]

Moist Heat or Steam Sterilization


[00810044842883]

Moist Heat or Steam Sterilization


[00810044842883]

Moist Heat or Steam Sterilization


[00810044842883]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-03
Device Publish Date2025-11-25

On-Brand Devices [OnePLUS Dental Implant]

00810044842906OPID-R-L
00810044842890OPID-R-S
00810044842883OPID-M-L
00810044842876OPID-M-S
00810044842869OFOS-2035
00810044842852OFLD-1833
00810044842845OFLD-1626
00810044842838OPIC-525
00810044842821OPIC-450
00810044842814OPIC-375
00810044842807OPIC-300
00810044842791OPIA-525
00810044842784OPIA-450
00810044842777OPIA-375
00810044842760OPIA-300

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