FDA device listing

DISPOSABLE XENON KITFOR NUCLEAR MEDICINE,Immobilization Kit, with

FDA device listing 1779764750 · UPS SUPPLY CHAIN SOLUTIONS, INC.

Key facts

Proprietary names DISPOSABLE XENON KITFOR NUCLEAR MEDICINE,Immobilization Kit, with
Owner/operator UPS SUPPLY CHAIN SOLUTIONS, INC.
Owner/operator number 9073670
Premarket submissions K953513
Product codes IYT
Device names IYT - System, Rebreathing, Radionuclide
Device class Class II
Classification regulations (21 CFR) 892.1390
Review panels Radiology
Registered establishments UPS SUPPLY CHAIN SOLUTIONS, INC.
Establishment registrations 3009171251
FEI numbers 3006759904
Establishment operations Repackager/Relabeler
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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