Removal Coring Tool, Distal Bead

Basic Information

• Brand Name: Removal Coring Tool, Distal Bead
• Primary DI: 10855068008850
• Version / Model: RKC-002
• Catalog Number: RKC-002
• Company Name: Curvafix Inc
• Labeler DUNS: 039779098
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-26
• Public Version: 1
• Public Version Date: 2023-10-04
• Public Version Status: New
• Public Device Record Key: ad1aa6c7-571a-40fc-9e27-d383e71de668

Device Description

A T-handled cutting instrument with a cannula used over a wire to manually remove bone in a cylindral shape around the Distal Bead of a CurvaFix Implant.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64337	Bone-coring punch, reusable	A hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10855068008850	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]