Guide Handle ODI-F08

GUDID B058ODIF081

Guide Handle

Orthopedic Designs North America, Inc.

Orthopaedic implant aiming arm

• Primary Device ID: B058ODIF081
• NIH Device Record Key: e177009a-827a-4867-8924-cc1db53b618e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide Handle
• Version Model Number: ODIF08
• Catalog Number: ODI-F08
• 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	B058ODIF081 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B058ODIF081]

Moist Heat or Steam Sterilization

[B058ODIF081]

Moist Heat or Steam Sterilization

[B058ODIF081]

Moist Heat or Steam Sterilization

[B058ODIF081]

Moist Heat or Steam Sterilization

[B058ODIF081]

Moist Heat or Steam Sterilization

[B058ODIF081]

Moist Heat or Steam Sterilization

[B058ODIF081]

Moist Heat or Steam Sterilization

[B058ODIF081]

Moist Heat or Steam Sterilization

[B058ODIF081]

Moist Heat or Steam Sterilization

[B058ODIF081]

Moist Heat or Steam Sterilization

[B058ODIF081]

Moist Heat or Steam Sterilization

[B058ODIF081]

Moist Heat or Steam Sterilization

[B058ODIF081]

Moist Heat or Steam Sterilization

[B058ODIF081]

Moist Heat or Steam Sterilization

[B058ODIF081]

Moist Heat or Steam Sterilization

[B058ODIF081]

Moist Heat or Steam Sterilization

[B058ODIF081]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-27
• Device Publish Date: 2023-06-19

On-Brand Devices [Guide Handle]

• B058SLNT03021: Guide Handle
• B058ODIT1011: Guide Handle
• B058ODIF081: Guide Handle