MTS

Basic Information

• Brand Name: MTS
• Primary DI: 00859151005286
• Version / Model: MTS101
• Catalog Number: MTS101
• Company Name: MEDICAPTURE, INC.
• Labeler DUNS: 788868904
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-21
• Public Version: 2
• Public Version Date: 2023-08-15
• Public Version Status: Update
• Public Device Record Key: 8e6b37c3-ee14-4672-9501-28c352e50a27
• Distribution End Date: 2027-11-02

Device Description

This touchscreen monitor is used for external operation of devices with a graphical user interface. Power is supplied via USB of the host device. Supply of graphic information (video signal) is via HDMI or DVI. The MTS has no operating elements. The start-up takes place automatically as soon as the supply voltage and the video signal are present and recognized.This device is intended as user interface (human-machine interface) for various medical devices. It is not intended for diagnostic purposes.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
FWB	Camera, Television, Surgical, Without Audio	General, Plastic Surgery	878.4160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36612	Image display unit, colour	An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This group of devices is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859151005286	GS1