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: Visicoil Multi-Market Patient Convenience Kit: Quantity of 8: SN-050-005-PL08. Which contains: 0.50mm x 0.5cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle. FDA UDI
Model / Reference: KIT-SPN-8PL FDA UDI
Description: Visicoil Multi-Market Patient Convenience Kit: Quantity of 8: SN-050-005-PL08. Which contains: 0.50mm x 0.5cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle. FDA UDI

Identifiers

Catalog Number: KIT-SPN-8PL FDA UDI
Primary DI / UDI-DI: EIBAKITSPN8PL0 FDA UDI
510(k) Number: K070305 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

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 e698ad21-3b08-45eb-af27-69fea0503c9d 36 fields · synced Jun 6, 2026