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mi-ultra CX

FDA UDI

Class II (US FDA UDI)

by Trice Medical, Inc.

Identity

Trade Name
mi-ultra CX FDA UDI
Generic Name
Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Device Name
Ultrasound Convex Transducer FDA UDI
Model / Reference
T900-021 FDA UDI
Description
Ultrasound Convex Transducer FDA UDI

Identifiers

Primary DI / UDI-DI
00857356008019 FDA UDI
510(k) Number
K163443 FDA UDI
FDA Product Code
IYO FDA UDI
IYN FDA UDI
ITX FDA UDI
GMDN Term
Extracorporeal ultrasound imaging transducer, hand-held FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
892.1550 FDA UDI
892.1570 FDA UDI
Commercial Distribution
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

Category: Extracorporeal ultrasound imaging transducer, hand-held

mi-ultra CX by Trice Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extracorporeal ultrasound imaging transducer, hand-held.

Cleared under the same submission

K163443 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Trice Medical, Inc.

Sources (1)

  • FDA UDI 051a6cdb-2d50-4133-b158-01f7a14ac73c 35 fields · synced May 30, 2026