FITBONE®

Basic Information

• Brand Name: FITBONE®
• Primary DI: 04260170141415
• Version / Model: GRID
• Catalog Number: 60001464
• Company Name: WITTENSTEIN intens GmbH
• Labeler DUNS: 315887799
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-12
• Public Version: 4
• Public Version Date: 2023-01-06
• Public Version Status: Update
• Public Device Record Key: 757325fd-d5c0-465a-964f-81dacb5685b5
• Distribution End Date: 2022-12-31

Device Description

GRID plate

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	888.3020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63074	Orthopaedic x-ray reference grid	A device designed to superimpose a reference grid over an x-ray image during an orthopaedic procedure (e.g., surgery). It is a flat plate made of x-ray translucent material with a grid that is not translucent and therefore shows up on the x-ray image. It is only intended to assist alignment of anatomical structures (bones) and is not intended to take an accurate measurement of length (i.e., not an x-ray ruler). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260170141415	GS1

Customer Contacts

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