Foerner Sesamoid Knife

Basic Information

• Brand Name: Foerner Sesamoid Knife
• Primary DI: 00192896105508
• Version / Model: 1404-875L
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-16
• Public Version: 1
• Public Version Date: 2020-11-24
• Public Version Status: New
• Public Device Record Key: d4279b4d-207a-4376-ab6c-3e1e6383fd4a

Device Description

Foerner Sesamoid Knife Single End Curved Heavy

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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTS	KNIFE, ORTHOPEDIC	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32850	Orthopaedic knife	A hand-held manual surgical instrument designed for cutting/shaping bone during an orthopaedic surgical intervention. It is typically a heavy, one-piece instrument with a sharp, single-edged, strong cutting blade at the distal end available in various shapes and sizes, with a handle at the proximal end. It is normally made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896105508	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	7.25	Inch
Device Size Text, specify			Tip 5.0 Millimeter