Steerable Guide Sleeve CGS-001

GUDID 10855068008225

A hand-held tubular surgical device designed to be used during an CurvaFix Implant implantation procedure to facilitate the acceptance of a Steerable Guide through it.

Curvafix Inc

Orthopaedic implantation sleeve, reusable

• Primary Device ID: 10855068008225
• NIH Device Record Key: 458c6acd-337a-49c8-be09-93b377d4f4a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Steerable Guide Sleeve
• Version Model Number: CGS-001
• Catalog Number: CGS-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: true
• Serial Number: false
• 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	10855068008225 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument
• HWC: Screw, Fixation, Bone

Sterilization

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

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

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 [Steerable Guide Sleeve]

• 10855068008225: A hand-held tubular surgical device designed to be used during an CurvaFix Implant implantation
• 10855068008478: A hand-held stainless steel tube used during a CurvaFix procedure to facilitate the acceptance o