Mx-Grafter

Basic Information

• Brand Name: Mx-Grafter
• Primary DI: 00860002195001
• Version / Model: 11302
• Company Name: MAXILON LABORATORIES INC
• Labeler DUNS: 949461941
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-02
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 90ae6be7-5d27-475d-acd6-45aab1b395c0

Device Description

The Mx-Grafter Bone Grafting System is a manual, self-contained, sterile, single use instrument for the removal, harvest, and grafting of autogenous bone in surgical applications. The instrument is comprised of a plastic handle and stainless steel blade. The blade shaves bone from cortical surfaces producing short convoluted ribbons. While being cut, shavings combine with blood and flow into the handle. This graft material, an osseous coagulum, is then delivered with the handle directly to the recipient site, or to a bowl.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	878.4800	1
EMI	File, Bone, Surgical	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63815	Bone collection scraper	A sterile, surgical device intended for the manual removal, through scraping, and collection of autogenous bone particles from a patient, typically as part of a dental surgical procedure. It consists of a handle with a scraping blade and a collection chamber. This is a single-use device.	No	Active
35559	Bone file/rasp, manual, reusable	A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860002195001	GS1

Customer Contacts

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