Torque Limiting Handle ODI-T119

GUDID B058ODIT1191

Torque Limiting Handle

Orthopedic Designs North America, Inc.

Surgical instrument handle, torque-limiting

• Primary Device ID: B058ODIT1191
• NIH Device Record Key: f69e03a6-f0cf-485e-af0f-589583971048
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Torque Limiting Handle
• Version Model Number: ODIT119
• Catalog Number: ODI-T119
• 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	B058ODIT1191 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B058ODIT1191]

Moist Heat or Steam Sterilization

[B058ODIT1191]

Moist Heat or Steam Sterilization

[B058ODIT1191]

Moist Heat or Steam Sterilization

[B058ODIT1191]

Moist Heat or Steam Sterilization

[B058ODIT1191]

Moist Heat or Steam Sterilization

[B058ODIT1191]

Moist Heat or Steam Sterilization

[B058ODIT1191]

Moist Heat or Steam Sterilization

[B058ODIT1191]

Moist Heat or Steam Sterilization

[B058ODIT1191]

Moist Heat or Steam Sterilization

[B058ODIT1191]

Moist Heat or Steam Sterilization

[B058ODIT1191]

Moist Heat or Steam Sterilization

[B058ODIT1191]

Moist Heat or Steam Sterilization

[B058ODIT1191]

Moist Heat or Steam Sterilization

[B058ODIT1191]

Moist Heat or Steam Sterilization

[B058ODIT1191]

Moist Heat or Steam Sterilization

[B058ODIT1191]

Moist Heat or Steam Sterilization

[B058ODIT1191]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-22
• Device Publish Date: 2024-07-12

On-Brand Devices [Torque Limiting Handle]

• B058SLNT051: Torque Limiting Handle
• B058ODIU071: Torque Limiting Handle
• B058ODIT1441: Torque Limiting Handle
• B058ODIT1191: Torque Limiting Handle