Ti-Max X

Basic Information

• Brand Name: Ti-Max X
• Primary DI: 04560264510906
• Version / Model: X55
• Company Name: NAKANISHI INC.
• Labeler DUNS: 690710546
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-05
• Public Version: 3
• Public Version Date: 2021-02-15
• Public Version Status: Update
• Public Device Record Key: 5f18a8c3-227e-41ef-82f6-f25db32f97d3
• Distribution End Date: 2021-02-15

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: Yes
• Has Lot/Batch Number: No
• 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
EGS	Handpiece, contra- and right-angle attachment, dental	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45574	Dental power tool converter attachment, non-rotary	A dental attachment, commonly known as a ratchet adaptor, drive converter, or dental turbine, designed to be fitted in a dental power tool handpiece to convert energy (e.g., electrical, pneumatic) to a sagittal, oscillating or reciprocating mechanical motion to achieve a specific function (e.g., sawing) during dental procedures [e.g., maxillofacial surgery]. It is not an endpiece; an appropriate interchangeable endpiece (e.g., saw blade) is intended to be fixed to the working end of this device. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04560264510906	GS1