FDA device listing

Medline Endo Kit,Medline Endoscope Introducer Kit

FDA device listing 2047542609 · Medline Industries, LP

Key facts

Proprietary names Medline Endo Kit,Medline Endoscope Introducer Kit
Owner/operator Medline Industries, LP
Owner/operator number 1417592
Product codes NWU
Device names NWU - Endoscope Introducer Kit
Device class Class II
Classification regulations (21 CFR) 876.1500
Review panels Gastroenterology & Urology
Registered establishments MEDLINE INDUSTRIES, LP - Laredo, Medline Industries, LP - Mexicali (MXC), MEDLINE INDUSTRIES, LP - SPT, Medline Soluciones Medicas, Nuevo Laredo Directo al Cliente, PRODUCTOS MEDLINE S.A. DE C.V.
Establishment registrations 1423395, 3004122598, 3005595283, 3015173212, 3045816902, 3045816907
FEI numbers 3000717925, 3004122598, 3005595283, 3015173212, 3045816902, 3045816907
Establishment operations Contract Sterilizer, Manufacturer, Repackager/Relabeler
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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