V files

Basic Information

• Brand Name: V files
• Primary DI: 04560264562974
• Version / Model: V-U20
• Company Name: NAKANISHI INC.
• Labeler DUNS: 690710546
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 7
• Public Version Date: 2023-10-20
• Public Version Status: Update
• Public Device Record Key: 72b5c386-aaeb-40ea-bb33-d97969b9e5ee

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: Yes
• 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
ELC	Scaler, ultrasonic	Dental	872.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64041	Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable	A removable endpiece intended to be attached to a pneumatic dental scaling/debridement system handpiece for the application of sonic vibrational energy (e.g., at a frequency of 6 kHz) to fragment/remove tissue during an endodontic procedure. It is available variety of forms and sizes, and is typically made of metal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04560264562974	GS1
Unit of Use	04560264565272	GS1

Premarket Submissions

Submission Number	Supplement Number
K991021	000