EZX

Basic Information

• Brand Name: EZX
• Primary DI: 08800038039698
• Version / Model: ITL038
• Company Name: IMEDICOM CO., LTD.
• Labeler DUNS: 690340653
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-29
• Public Version: 1
• Public Version Date: 2020-06-08
• Public Version Status: New
• Public Device Record Key: 62482237-2d4a-40b4-97ea-9fd0baced9b4

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43663	Sawing power tool attachment, sagittal	A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a sagittal sawing function when a sagittal saw blade is inserted. This attachment is designed with the cutting teeth arranged in an arc at the distal end pointing directly forward and cuts when the blade is powered in a rapid oscillating (side to side) movement. It is typically made of high-grade stainless steel and synthetic materials and is typically of the macro design. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800038039698	GS1