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Ezu-Pa5c1

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name
EZU-PA5C1 FDA UDI
Generic Name
Ultrasound imaging system tracking positioner, reusable FDA UDI
Device Name
Needle Guide Bracket FDA UDI
Model / Reference
EZU-PA5C1 FDA UDI
Description
Needle Guide Bracket FDA UDI

Identifiers

Primary DI / UDI-DI
04573596210888 FDA UDI
510(k) Number
K093466 FDA UDI
K102901 FDA UDI
K110673 FDA UDI
FDA Product Code
IYO FDA UDI
IYN FDA UDI
ITX FDA UDI
GMDN Term
Ultrasound imaging system tracking positioner, reusable 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: Ultrasound imaging system tracking positioner, reusable

Ezu-Pa5c1 by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasound imaging system tracking positioner, reusable.

Cleared under the same submission

K093466 also covers:

K102901 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FUJIFILM Corporation

Sources (1)

  • FDA UDI dd3e9fa4-d713-4c6f-b0e7-be7839df0493 34 fields · synced May 30, 2026