Gold Fiducial

FDA UDI

Class II (US FDA UDI)

by Izi Medical Products Llc

Identity

Trade Name: Gold Fiducial FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: 0.8mm x 3mm Gold Fiducial Marker Loose FDA UDI
Model / Reference: GF0302 FDA UDI
Description: 0.8mm x 3mm Gold Fiducial Marker Loose FDA UDI

Identifiers

Catalog Number: GF0302 FDA UDI
Primary DI / UDI-DI: B887GF03020 FDA UDI
510(k) Number: K161724 FDA UDI
FDA Product Code: JAK FDA UDI
IYE FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1750 FDA UDI
892.5050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Radiological image marker, implantable

Gold Fiducial by Izi Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Izi Medical Products Llc

Sources (1)

FDA UDI 04adb833-1735-410d-b0c0-c9e8f436f9ed 36 fields · synced Jun 1, 2026