Cortical Drill

GUDID 08800011262938

Point Nix Co., Ltd.

Fixture/appliance dental drill bit, reusable

• Primary Device ID: 08800011262938
• NIH Device Record Key: c91a4381-c272-4acd-9d4d-64c83b8995e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cortical Drill
• Version Model Number: OTCD3500
• Company DUNS: 695333960
• Company Name: Point Nix Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800011262938 [Primary]

FDA Product Code

• DZA: Drill, Dental, Intraoral

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

[08800011262938]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-28
• Device Publish Date: 2022-02-18

On-Brand Devices [Cortical Drill]

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