AccessGUDID - DEVICE: Mx-Grafter (00860002195001)

GUDID

Device Identifier (DI) Information

Brand Name: Mx-Grafter
Version or Model: 11302
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MAXILON LABORATORIES INC

Primary DI Number: 00860002195001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 949461941 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAC	Rasp, Surgical, General & Plastic Surgery
EMI	File, Bone, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 90ae6be7-5d27-475d-acd6-45aab1b395c0
Public Version Date: June 10, 2022
Public Version Number: 2
DI Record Publish Date: March 02, 2020