Packaged System, Kavo Nomad Pro2, GBL

Basic Information

• Brand Name: Packaged System, Kavo Nomad Pro2, GBL
• Primary DI: EKAV101320410
• Version / Model: 1.013.2041
• Catalog Number: 1.013.2041
• Company Name: ARIBEX, INC.
• Labeler DUNS: 169065526
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-21
• Public Version: 1
• Public Version Date: 2020-03-02
• Public Version Status: New
• Public Device Record Key: 761398b7-7888-4a58-b51c-6d7272aa99c2

Device Description

this is a medical device

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHD	UNIT, X-RAY, EXTRAORAL WITH TIMER	Dental	872.1800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37607	Diagnostic x-ray system generator, hand-held	An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a hand-held x-ray system, e.g., a system that is held during operation. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). It includes transformer and inverter generator designs. A hand-held x-ray system generators typically comprises a control assembly (console) and high voltage transformer assembly, but can also be a mono-tank generator design.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EKAV101320410	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173319	000