FDA device listing

Valencia Ft Skin Applicator Set,Valencia Skin Applicator Set

FDA device listing 2033520390 · Nucletron B.V.

Key facts

Proprietary names Valencia Ft Skin Applicator Set,Valencia Skin Applicator Set
Owner/operator Nucletron B.V.
Owner/operator number 8030474
Premarket submissions K073107
Product codes JAQ
Device names JAQ - System, Applicator, Radionuclide, Remote-Controlled
Device class Class II
Classification regulations (21 CFR) 892.5700
Review panels Radiology
Registered establishments NUCLETRON B.V.
Establishment registrations 9611894
FEI numbers 3002807741
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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