Cortical Drill

GUDID 08800011262945

Point Nix Co., Ltd.

Fixture/appliance dental drill bit, reusable
Primary Device ID08800011262945
NIH Device Record Key9ed00c7b-4194-4493-af29-173820833f0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCortical Drill
Version Model NumberOTCD4000
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
GS108800011262945 [Primary]

FDA Product Code

DZADrill, Dental, Intraoral

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


[08800011262945]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-28
Device Publish Date2022-02-18

On-Brand Devices [Cortical Drill]

08800011262969OTCD5000
08800011262952OTCD4500
08800011262945OTCD4000
08800011262938OTCD3500
08800011262921OTCD3000
08800011263003OTCD7000
08800011262990OTCD6500
08800011262983OTCD6000
08800011262976OTCD5500

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