FO Micro Screw System

Basic Information

• Brand Name: FO Micro Screw System
• Primary DI: 09353903002505
• Version / Model: CPN000027
• Catalog Number: BTSC00027
• Company Name: FIELD ORTHOPAEDICS PTY LTD
• Labeler DUNS: 744008914
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-19
• Public Version: 1
• Public Version Date: 2020-05-27
• Public Version Status: New
• Public Device Record Key: 052a2cef-0ce6-405d-8342-169c6afff646

Device Description

FO Countersink (Cannulated)

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: No
• 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
HWW	Countersink	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16462	Surgical countersink, reusable	A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09353903002505	GS1