Visicoil Mr

FDA UDI

Class II (US FDA UDI)

by Izi Medical Products Llc

Identity

Trade Name: VISICOIL MR FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: 0.5mm x 1.0cm VISICOIL MR Platinum loaded in an 19 gauge x 20 cm pre-waxed needle FDA UDI
Model / Reference: MR-050-010-1920 FDA UDI
Description: 0.5mm x 1.0cm VISICOIL MR Platinum loaded in an 19 gauge x 20 cm pre-waxed needle FDA UDI

Identifiers

Catalog Number: MR-050-010-1920 FDA UDI
Primary DI / UDI-DI: B887MR05001019200 FDA UDI
510(k) Number: K161724 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 Unsafe FDA UDI

Category: Radiological image marker, implantable

Visicoil Mr 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 04bc1609-9e67-4edf-a979-c58b89019b91 36 fields · synced May 31, 2026