Torque Limiting Handle CTH-001

GUDID 10855068008379

A surgical instrument that allows a surgeon to insert the CurvaFix IM Implant into the pelvis without exerting excess torque or force on the implant.

Curvafix Inc

Surgical instrument handle, torque-limiting

• Primary Device ID: 10855068008379
• NIH Device Record Key: ab1747e5-eddf-4ace-b203-1bd7bd6d8fe5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Torque Limiting Handle
• Version Model Number: CTH-001
• Catalog Number: CTH-001
• Company DUNS: 039779098
• Company Name: Curvafix 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: false
• Serial Number: true
• Manufacturing Date: false
• 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: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10855068008379 [Primary]

FDA Product Code

• HWC: Screw, Fixation, Bone
• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-19
• Device Publish Date: 2021-08-11

On-Brand Devices [Torque Limiting Handle]

• 10855068008379: A surgical instrument that allows a surgeon to insert the CurvaFix IM Implant into the pelvis wi
• 10855068008430: A surgical instrument that allows a surgeon to insert the CurvaFix IM Implant into the pelvis wi