FOREFOOT SOLUTIONS™

Basic Information

• Brand Name: FOREFOOT SOLUTIONS™
• Primary DI: 10381780043119
• Version / Model: 229012ND
• Catalog Number: 229012ND
• Company Name: NEWDEAL
• Labeler DUNS: 536935331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-26
• Public Version: 2
• Public Version Date: 2023-02-06
• Public Version Status: Update
• Public Device Record Key: 5efd8d68-ab72-436f-830d-9155605cfd9c
• Distribution End Date: 2027-07-11

Device Description

FF2 TRANSVERSAL CUTTING GUIDE - The transversal cutting guide is used to guide the saw blade during bone resection. It has a slot of 0.8mm width and 13mm length in which the saw blade is inserted.

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: Yes
• 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: 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
FZX	Guide, surgical, instrument	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45109	Orthopaedic reamer guide	An orthopaedic surgical device that functions as a guide for an orthopaedic reamer. The guide, commonly called a spigot, is inserted into a predetermined site where bone is to be resected for the acceptance of a prosthetic implant, typically at or within a joint (e.g., the condyle head of the knee, the olecranon of the ulna) or for the reaming of the intramedullary canal for acceptance of an intramedullary nail. The device allows the controlled cutting action of the reamer which is steered down its length. It is typically made of a high-grade stainless steel alloy; it comes in varying sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M248229012ND1	HIBCC
Primary	10381780043119	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	15	Millimeter
Device Size Text, specify			10mm height
Width	11	Millimeter