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Ust-5543

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name
UST-5543 FDA UDI
Generic Name
Surgical ultrasound imaging transducer FDA UDI
Device Name
Probe FDA UDI
Model / Reference
UST-5543 FDA UDI
Description
Probe FDA UDI

Identifiers

Primary DI / UDI-DI
04573596212899 FDA UDI
FDA Product Code
IYO FDA UDI
IYN FDA UDI
ITX FDA UDI
GMDN Term
Surgical ultrasound imaging transducer 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: Surgical ultrasound imaging transducer

Ust-5543 by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical ultrasound imaging transducer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FUJIFILM Corporation

Sources (1)

  • FDA UDI 09f0ac1b-6245-4e75-8f5e-f0fb8fa479e9 34 fields · synced May 30, 2026