FDA device listing

Check-Flo Performer Introducer

FDA device listing 1297933419 · Goodwill Commercial Services

Key facts

Proprietary names Check-Flo Performer Introducer
Owner/operator Goodwill Commercial Services
Owner/operator number 10095086
Product codes DYB
Device names DYB - Introducer, Catheter
Device class Class II
Classification regulations (21 CFR) 870.1340
Review panels Cardiovascular
Registered establishments GOODWILL COMMERCIAL SERVICES
Establishment registrations 3043337628
FEI numbers 3043337628
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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