Cortical Drill ODI-T109

GUDID B058ODIT1091

Cortical Drill, 3.4mm

Orthopedic Designs North America, Inc.

Fluted surgical drill bit, reusable

• Primary Device ID: B058ODIT1091
• NIH Device Record Key: 5f6a9615-6a79-4195-ba5e-128dc00c51f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cortical Drill
• Version Model Number: ODIT109
• Catalog Number: ODI-T109
• Company DUNS: 945518848
• Company Name: Orthopedic Designs North America, Inc.
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B058ODIT1091 [Primary]

FDA Product Code

• HTW: Bit, Drill

Sterilization

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

[B058ODIT1091]

Moist Heat or Steam Sterilization

[B058ODIT1091]

Moist Heat or Steam Sterilization

[B058ODIT1091]

Moist Heat or Steam Sterilization

[B058ODIT1091]

Moist Heat or Steam Sterilization

[B058ODIT1091]

Moist Heat or Steam Sterilization

[B058ODIT1091]

Moist Heat or Steam Sterilization

[B058ODIT1091]

Moist Heat or Steam Sterilization

[B058ODIT1091]

Moist Heat or Steam Sterilization

[B058ODIT1091]

Moist Heat or Steam Sterilization

[B058ODIT1091]

Moist Heat or Steam Sterilization

[B058ODIT1091]

Moist Heat or Steam Sterilization

[B058ODIT1091]

Moist Heat or Steam Sterilization

[B058ODIT1091]

Moist Heat or Steam Sterilization

[B058ODIT1091]

Moist Heat or Steam Sterilization

[B058ODIT1091]

Moist Heat or Steam Sterilization

[B058ODIT1091]

Moist Heat or Steam Sterilization

[B058ODIT1091]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-03
• Device Publish Date: 2023-06-23

On-Brand Devices [Cortical Drill]

• B058ODIT1091: Cortical Drill, 3.4mm
• B058ODIF161: Cortical Drill, 4.2mm