Jones Screw Instrument Kit for 5.5mm Screw

Basic Information

• Brand Name: Jones Screw Instrument Kit for 5.5mm Screw
• Primary DI: 00840118114585
• Version / Model: FJS 100
• Company Name: FLOWER ORTHOPEDICS CORPORATION
• Labeler DUNS: 078790947
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-01
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: 8d0a25ef-d399-4803-a37f-8d5bab2c9d76

Device Description

surgical instrument or accessory for orthopedic bone fixation

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTY	Pin, Fixation, Smooth	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47634	Surgical countersink, single-use	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 single-use device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840118114585	GS1