Ratcheting Axial Handle ODI-U05

GUDID B058ODIU051

Ratcheting Axial Handle

Orthopedic Designs North America, Inc.

Surgical instrument handle, non-torque-limiting

• Primary Device ID: B058ODIU051
• NIH Device Record Key: 1446f3c4-b46f-4861-bc25-4315ab86e570
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ratcheting Axial Handle
• Version Model Number: ODIU05
• Catalog Number: ODI-U05
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B058ODIU051 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B058ODIU051]

Moist Heat or Steam Sterilization

[B058ODIU051]

Moist Heat or Steam Sterilization

[B058ODIU051]

Moist Heat or Steam Sterilization

[B058ODIU051]

Moist Heat or Steam Sterilization

[B058ODIU051]

Moist Heat or Steam Sterilization

[B058ODIU051]

Moist Heat or Steam Sterilization

[B058ODIU051]

Moist Heat or Steam Sterilization

[B058ODIU051]

Moist Heat or Steam Sterilization

[B058ODIU051]

Moist Heat or Steam Sterilization

[B058ODIU051]

Moist Heat or Steam Sterilization

[B058ODIU051]

Moist Heat or Steam Sterilization

[B058ODIU051]

Moist Heat or Steam Sterilization

[B058ODIU051]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-29
• Device Publish Date: 2023-06-21

On-Brand Devices [Ratcheting Axial Handle]

• B058SLNT041: Ratcheting Axial Handle
• B058ODIU051: Ratcheting Axial Handle
• B058ODIT1201: Ratcheting Axial Handle