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Trinity

FDA UDI

Class II (US FDA UDI)

by Koelis

Identity

Trade Name
TRINITY FDA UDI
Generic Name
General-purpose ultrasound imaging system FDA UDI
Device Name
A mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart, Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse. FDA UDI
Model / Reference
KURO3000-2 FDA UDI
Description
A mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart, Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse. FDA UDI

Identifiers

Primary DI / UDI-DI
03665134000035 FDA UDI
FDA Product Code
IYO FDA UDI
IYN FDA UDI
LLZ FDA UDI
ITX FDA UDI
GMDN Term
General-purpose ultrasound imaging system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
892.1550 FDA UDI
892.2050 FDA UDI
892.1570 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Trinity by Koelis — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Koelis

Sources (1)

  • FDA UDI e855f1be-b0a7-4cc9-af58-c87ffdf8d065 36 fields · synced May 30, 2026