Modular Flexible Reamer Shaft SLN-T01

GUDID B058SLNT011

Modular Flexible Reamer Shaft

Orthopedic Designs North America, Inc.

Medullary canal orthopaedic reamer, rigid

• Primary Device ID: B058SLNT011
• NIH Device Record Key: 5c7e6240-635b-46ec-8284-984730d02efc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modular Flexible Reamer Shaft
• Version Model Number: SLNT01
• Catalog Number: SLN-T01
• 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	B058SLNT011 [Primary]

FDA Product Code

• HTO: Reamer

Sterilization

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

[B058SLNT011]

Moist Heat or Steam Sterilization

[B058SLNT011]

Moist Heat or Steam Sterilization

[B058SLNT011]

Moist Heat or Steam Sterilization

[B058SLNT011]

Moist Heat or Steam Sterilization

[B058SLNT011]

Moist Heat or Steam Sterilization

[B058SLNT011]

Moist Heat or Steam Sterilization

[B058SLNT011]

Moist Heat or Steam Sterilization

[B058SLNT011]

Moist Heat or Steam Sterilization

[B058SLNT011]

Moist Heat or Steam Sterilization

[B058SLNT011]

Moist Heat or Steam Sterilization

[B058SLNT011]

Moist Heat or Steam Sterilization

[B058SLNT011]

Moist Heat or Steam Sterilization

[B058SLNT011]

Moist Heat or Steam Sterilization

[B058SLNT011]

Moist Heat or Steam Sterilization

[B058SLNT011]

Moist Heat or Steam Sterilization

[B058SLNT011]

Moist Heat or Steam Sterilization

[B058SLNT011]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-04
• Device Publish Date: 2023-06-26

Devices Manufactured by Orthopedic Designs North America, Inc.

• B058AHN08255L1 - Atlas™ Humeral Nail System: 2025-06-25 Atlas Humeral Nail System - Nail Ø8mm | 255mm | Left
• B058AHN08255R1 - Atlas™ Humeral Nail System: 2025-06-25 Atlas Humeral Nail System - Nail Ø8mm | 255mm | Right
• B058AHN08270L1 - Atlas™ Humeral Nail System: 2025-06-25 Atlas Humeral Nail System - Nail Ø8mm | 270mm | Left
• B058AHN08270R1 - Atlas™ Humeral Nail System: 2025-06-25 Atlas Humeral Nail System - Nail Ø8mm | 270mm | Right
• B058AHN5034NS1 - Atlas™ Humeral Nail System: 2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 034mm (non-sterile)
• B058AHN5036NS1 - Atlas™ Humeral Nail System: 2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 036mm (non-sterile)
• B058AHN5038NS1 - Atlas™ Humeral Nail System: 2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 038mm (non-sterile)
• B058AHN5040NS1 - Atlas™ Humeral Nail System: 2025-06-02 Atlas Humeral Nail System Cortical Locking Screw: Ø5mm x 040mm (non-sterile)