FDA device listing

Stitching Platform with Handles/ Clear Stitching Stand

FDA device listing 2070928094 · REINA IMAGING

Key facts

Proprietary names Stitching Platform with Handles/ Clear Stitching Stand
Owner/operator REINA IMAGING
Owner/operator number 1450835
Product codes KXH
Device names KXH - Cradle, Patient, Radiologic
Device class Class I
Classification regulations (21 CFR) 892.1830
Review panels Radiology
Registered establishments REINA IMAGING
Establishment registrations 1450835
FEI numbers 1450835
Establishment operations 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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