Osteotome

GUDID 08800011260040

Point Nix Co., Ltd.

Dental osteotome
Primary Device ID08800011260040
NIH Device Record Key631a52b7-315d-4b8f-8b2d-61bb6eb6083b
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteotome
Version Model NumberOST28
Company DUNS695333960
Company NamePoint Nix Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800011260040 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


[08800011260040]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-01
Device Publish Date2022-02-21

On-Brand Devices [Osteotome]

08800011260088OSTM
08800011260071OST42
08800011260064OST37
08800011260057OST33
08800011260040OST28

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