LumiCoil™

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name: LumiCoil™ FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: Platinum Fiducial Marker FDA UDI
Model / Reference: M00553840 FDA UDI
Description: Platinum Fiducial Marker FDA UDI

Identifiers

Primary DI / UDI-DI: 08714729972884 FDA UDI
FDA Product Code: IYE FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

MRI Safety

MR Conditional FDA UDI

Category: Radiological image marker, implantable

LumiCoil™ by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Boston Scientific

Sources (1)

FDA UDI d6663ff2-cd94-401b-8a5c-dcd2cb78d042 34 fields · synced May 31, 2026