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Multi-Modality Markers

FDA UDI

Class II (US FDA UDI)

by Izi Medical Products Llc

Identity

Trade Name
Multi-Modality Markers FDA UDI
Generic Name
Radiological image marker, noninvasive, single-use FDA UDI
Model / Reference
960-991 FDA UDI

Identifiers

Primary DI / UDI-DI
10815212020268 FDA UDI
510(k) Number
K014022 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Radiological image marker, noninvasive, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Multi-Modality Markers by Izi Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K014022 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 de2020b2-92f8-419a-8438-1c56d5fb28f9 34 fields · synced Jun 8, 2026