FDA device listing

ASiR-V

FDA device listing 1502303029 · Gexpro, A Division of Rexel USA, Inc.

Key facts

Proprietary names ASiR-V
Owner/operator Gexpro, A Division of Rexel USA, Inc.
Owner/operator number 10027980
Product codes JAK
Device names JAK - System, X-Ray, Tomography, Computed
Device class Class II
Classification regulations (21 CFR) 892.1750
Review panels Radiology
Registered establishments GEXPRO, a Division of REXEL USA, Inc.
Establishment registrations 3007545404
FEI numbers 3007545404
Establishment operations Contract Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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