Varex Imaging XRpad2 HWC-M Digital X-ray Manual De Usuario página 35

Unique Device Identifier - UDI
11.0 Unique Device Identifier - UDI
UDI data is placed on Varex Imaging XRpad Digital X-ray medical device detectors. It is a
unique device identification system, established by the FDA, to "adequately identify medical
devices sold in the US from manufacturing through distribution to patient use"
11.1 US FDA- UDI
The UDI data is found on the medical device label applied to the X-ray detector. A data-matrix
code (machine readable) and human readable information which contains the Device identifier
(01), manufacturing date (11), and X-ray detector serial number (21). A sample of this
information is displayed in
Figure 2 Sample XRpad2 X-ray Detector Label
The UDI data for the XRpad2 Digital X-ray medical device detectors are listed below:
Table 6 XRpad2 HWC-M X-ray Detectors — United States
X-ray
Part Number
Detector
XRpad2 3025 95510991
XRpad2 4336 95510981
XRpad2 4343 95510607
a. UDI Basics - United States Food and Drugs Administration (FDA) medical devices website.
b. This is only a sample detector label. Labels may change on the detector at any time without notice.
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Figure 2 below.
b
Santa Clara
00810751030030
00810751030047
00810751030009
www.vareximaging.com
XRpad2 HWC-M Detectors User Manual
FDA UDI — DI
Salt Lake City
00810751030078
00810751030085
00810751030092
a
.