Guidewire Kit CGK-001

GUDID 10855068008119

A single use kit, composed of a sterile packaged Steerable Guide, Driving Guidewire and Exchange Tube, that is used during a surgical procedure for the placement of the CurvaFix IM Implant.

Curvafix Inc

Bone nail guidewire, single-use

• Primary Device ID: 10855068008119
• NIH Device Record Key: 8fc88f7d-4247-4ef1-82e6-1170c25af894
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guidewire Kit
• Version Model Number: CGK-001
• Catalog Number: CGK-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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• 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	10855068008119 [Primary]

FDA Product Code

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

Sterilization

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

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

Devices Manufactured by Curvafix Inc

• 10855068008744 - Removal Drill, 9.5mm: 2023-10-04 A cannulated drill bit that attaches to a surgical power tool. It is used over a guide pin to remove bone leading up to or cover
• 10855068008751 - Removal Drill, 13.0 mm: 2023-10-04 A cannulated drill bit that attaches to a surgical power tool. It is used over a guide pin to remove bone leading up to or cover
• 10855068008768 - Tissue Sleeve, Removal Tool: 2023-10-04 A hand-held stainless steel tube used during a CurvaFix Implant removal to maintain direct access to the Implant head and protec
• 10855068008782 - Pin Sleeve, Removal Tool: 2023-10-04 A hand-held stainless steel tube used during a CurvaFix Implant removal that fits inside the Tissue Sleeve and contains a conica
• 10855068008829 - Removal Tool Set: 2023-10-04 A custom engineered set of reusable surgical instruments, housed in a sterilizable storage container, that are used to remove a
• 10855068008836 - Sterilization Case, Removal Tool Set: 2023-10-04 A reusable instrument storage case that can house and retain the reusable instruments of the Removal Tool Set during sterilizati
• 10855068008843 - Removal Coring Tool, Proximal Head: 2023-10-04 A T-handled cutting instrument with a cannula used over a wire to manually remove bone in a cylindral shape around the proximal
• 10855068008850 - Removal Coring Tool, Distal Bead: 2023-10-04 A T-handled cutting instrument with a cannula used over a wire to manually remove bone in a cylindral shape around the Distal Be