Handle-Arm Screw ODI-U11

GUDID B058ODIU111

Handle-Arm Screw

Orthopedic Designs North America, Inc.

Orthopaedic instrument surgical connector

• Primary Device ID: B058ODIU111
• NIH Device Record Key: af069659-8e53-4a3e-b071-f107cd149cbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Handle-Arm Screw
• Version Model Number: ODIU11
• Catalog Number: ODI-U11
• 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	B058ODIU111 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B058ODIU111]

Moist Heat or Steam Sterilization

[B058ODIU111]

Moist Heat or Steam Sterilization

[B058ODIU111]

Moist Heat or Steam Sterilization

[B058ODIU111]

Moist Heat or Steam Sterilization

[B058ODIU111]

Moist Heat or Steam Sterilization

[B058ODIU111]

Moist Heat or Steam Sterilization

[B058ODIU111]

Moist Heat or Steam Sterilization

[B058ODIU111]

Moist Heat or Steam Sterilization

[B058ODIU111]

Moist Heat or Steam Sterilization

[B058ODIU111]

Moist Heat or Steam Sterilization

[B058ODIU111]

Moist Heat or Steam Sterilization

[B058ODIU111]

Moist Heat or Steam Sterilization

[B058ODIU111]

Moist Heat or Steam Sterilization

[B058ODIU111]

Moist Heat or Steam Sterilization

[B058ODIU111]

Moist Heat or Steam Sterilization

[B058ODIU111]

Moist Heat or Steam Sterilization

[B058ODIU111]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-28
• Device Publish Date: 2023-06-20

Devices Manufactured by Orthopedic Designs North America, Inc.

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• B058CCD7516045NS1 - Cannulated Compression Device (CCD) System: 2024-07-29 Cannulated Compression Device - 045mm - 16mm (non-sterile)
• B058CCD7516050NS1 - Cannulated Compression Device (CCD) System: 2024-07-29 Cannulated Compression Device - 050mm - 16mm (non-sterile)
• B058CCD7516055NS1 - Cannulated Compression Device (CCD) System: 2024-07-29 Cannulated Compression Device - 055mm - 16mm (non-sterile)
• B058CCD7516060NS1 - Cannulated Compression Device (CCD) System: 2024-07-29 Cannulated Compression Device - 060mm - 16mm (non-sterile)
• B058CCD7516065NS1 - Cannulated Compression Device (CCD) System: 2024-07-29 Cannulated Compression Device - 065mm - 16mm (non-sterile)
• B058CCD7516070NS1 - Cannulated Compression Device (CCD) System: 2024-07-29 Cannulated Compression Device - 070mm - 16mm (non-sterile)