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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
0.50mm x 0.5cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle. FDA UDI
Model / Reference
SN-050-005-PL15 FDA UDI
Description
0.50mm x 0.5cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle. FDA UDI

Identifiers

Catalog Number
SN-050-005-PL15 FDA UDI
Primary DI / UDI-DI
EIBASN050005PL150 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Conditional FDA UDI

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

Cleared under the same submission

K070305 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Izi Medical Products Llc

Sources (1)

  • FDA UDI 114e4609-b6b0-4dfe-a53f-6aee9a3419ab 37 fields · synced Jun 1, 2026