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Registration Marker Kit, Sterile, Single

FDA UDI

Class II (US FDA UDI)

by MediView XR

Identity

Trade Name
Registration Marker Kit, Sterile, Single FDA UDI
Generic Name
Electromagnetic device tracking system spatial marker FDA UDI
Device Name
MediView single sterile Registration Marker kit for use with XR90. FDA UDI
Model / Reference
SPEC-0303 FDA UDI
Description
MediView single sterile Registration Marker kit for use with XR90. FDA UDI

Identifiers

Primary DI / UDI-DI
00850044606016 FDA UDI
510(k) Number
K223125 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Electromagnetic device tracking system spatial marker FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Electromagnetic surgical navigation device tracking systemElectromagnetic device tracking system spatial marker

Registration Marker Kit, Sterile, Single by MediView XR — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromagnetic device tracking system spatial marker.

Cleared under the same submission

K223125 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MediView XR

Sources (1)

  • FDA UDI 3d166d99-3d39-48ce-98bc-c40588c01369 34 fields · synced Jun 9, 2026