Screw Sleeve ODI-F13

GUDID B058ODIF131

Screw Sleeve

Orthopedic Designs North America, Inc.

Surgical drill guide, reusable

• Primary Device ID: B058ODIF131
• NIH Device Record Key: 0b3c2a97-498f-4e63-8051-512ae4addd77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Screw Sleeve
• Version Model Number: ODIF13
• Catalog Number: ODI-F13
• 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	B058ODIF131 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B058ODIF131]

Moist Heat or Steam Sterilization

[B058ODIF131]

Moist Heat or Steam Sterilization

[B058ODIF131]

Moist Heat or Steam Sterilization

[B058ODIF131]

Moist Heat or Steam Sterilization

[B058ODIF131]

Moist Heat or Steam Sterilization

[B058ODIF131]

Moist Heat or Steam Sterilization

[B058ODIF131]

Moist Heat or Steam Sterilization

[B058ODIF131]

Moist Heat or Steam Sterilization

[B058ODIF131]

Moist Heat or Steam Sterilization

[B058ODIF131]

Moist Heat or Steam Sterilization

[B058ODIF131]

Moist Heat or Steam Sterilization

[B058ODIF131]

Moist Heat or Steam Sterilization

[B058ODIF131]

Moist Heat or Steam Sterilization

[B058ODIF131]

Moist Heat or Steam Sterilization

[B058ODIF131]

Moist Heat or Steam Sterilization

[B058ODIF131]

Moist Heat or Steam Sterilization

[B058ODIF131]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-23
• Device Publish Date: 2023-08-15

On-Brand Devices [Screw Sleeve]

• B058ODIT1041: Screw Sleeve
• B058ODIF131: Screw Sleeve