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Trinias

FDA UDI

Class II (US FDA UDI)

by Shimadzu Corp.

Identity

Trade Name
Trinias FDA UDI
Generic Name
Stationary angiographic x-ray system, digital FDA UDI
Model / Reference
503-79402-32 FDA UDI

Identifiers

Primary DI / UDI-DI
04540217049073 FDA UDI
510(k) Number
K123508 FDA UDI
FDA Product Code
JAA FDA UDI
OWB FDA UDI
GMDN Term
Stationary angiographic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

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: Stationary angiographic x-ray system, digital

Trinias by Shimadzu Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary angiographic x-ray system, digital.

Cleared under the same submission

K123508 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shimadzu Corp.

Sources (1)

  • FDA UDI ae6f0629-efcc-487e-996f-2fab7f5947f6 33 fields · synced May 30, 2026