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Fiducial Markers

FDA UDI

Class II (US FDA UDI)

by Medtec LLC

Identity

Trade Name
Fiducial Markers FDA UDI
Generic Name
Radiological image marker, implantable FDA UDI
Device Name
Sterile (1.0 x 5mm) CyberMark soft tissue gold markers FDA UDI
Model / Reference
MTNW887852 FDA UDI
Description
Sterile (1.0 x 5mm) CyberMark soft tissue gold markers FDA UDI

Identifiers

Catalog Number
MTNW887852 FDA UDI
Primary DI / UDI-DI
00841439109762 FDA UDI
510(k) Number
K071614 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
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

Yes

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

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Length — 0.2 Inch FDA UDI

Fiducial Markers by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K071614 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtec LLC

Sources (1)

  • FDA UDI 897b24c5-bf44-417b-bd9a-a18a05ec438d 39 fields · synced May 30, 2026