Duns Number:083999244
Device Description: The NuCART® is a mobile display and image management platform intended to be used by healt The NuCART® is a mobile display and image management platform intended to be used by health care providersin Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signalsfrom source devices to monitors. It is tailored for use with a C-arm and Endo-Cam in MIS surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites.
Catalog Number
-
Brand Name
NuCART
Version/Model Number
NuCART
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LMD
Product Code Name
System, Digital Image Communications, Radiological
Public Device Record Key
5adff859-2f75-4282-acdd-6f06b02c0cc0
Public Version Date
January 05, 2021
Public Version Number
1
DI Record Publish Date
December 28, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |