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Xr-Mx/1000

FDA UDI

Class II (US FDA UDI)

by Storz Medical AG

Identity

Trade Name
XR-MX/1000 FDA UDI
Generic Name
Stationary uro-gynaecological fluoroscopic x-ray system, digital FDA UDI
Device Name
The XR-MX/1000 system is a solid-state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimally invasive urological surgery). The system may be used for urological treatment, planning and diagnostic procedures. FDA UDI
Model / Reference
FD43 (50 kW) FDA UDI
Description
The XR-MX/1000 system is a solid-state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimally invasive urological surgery). The system may be used for urological treatment, planning and diagnostic procedures. FDA UDI

Identifiers

Catalog Number
29254 FDA UDI
Primary DI / UDI-DI
07630039101053 FDA UDI
510(k) Number
K200965 FDA UDI
FDA Product Code
JAA FDA UDI
GMDN Term
Stationary uro-gynaecological fluoroscopic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Stationary uro-gynaecological fluoroscopic x-ray system, digital

Xr-Mx/1000 by Storz Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary uro-gynaecological fluoroscopic x-ray system, digital.

Cleared under the same submission

K200965 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Storz Medical AG

Sources (1)

  • FDA UDI fded0f40-d0a1-4510-9841-9404a83840c2 35 fields · synced May 29, 2026