Visicoil

FDA UDI

Class II (US FDA UDI)

by Izi Medical Products Llc

Identity

Trade Name: VISICOIL FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: 0.35mm x 0.5cm VISICOIL loaded into an 22 gauge pre-waxed needle. FDA UDI
Model / Reference: SN-035-005-PL08 FDA UDI
Description: 0.35mm x 0.5cm VISICOIL loaded into an 22 gauge pre-waxed needle. FDA UDI

Identifiers

Catalog Number: SN-035-005-PL08 FDA UDI
Primary DI / UDI-DI: B887SN035005PL080 FDA UDI
510(k) Number: K070305 FDA UDI
FDA Product Code: IYE FDA UDI
JAK FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5050 FDA UDI
892.1750 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 Conditional FDA UDI

Category: Radiological image marker, implantable

Visicoil 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 bf4ec5d7-1cc6-4016-9f5a-578a0c4f4dd2 36 fields · synced May 30, 2026