FDA device listing

Medline Baumgartner Needle Holder,Medline / Konig Holder, Needle, Gastroenterologic

FDA device listing 2040572079 · Medline Industries, LP

Key facts

Proprietary names Medline Baumgartner Needle Holder,Medline / Konig Holder, Needle, Gastroenterologic
Owner/operator Medline Industries, LP
Owner/operator number 1417592
Product codes FHQ
Device names FHQ - Holder, Needle, Gastroenterologic
Device class Class I
Classification regulations (21 CFR) 876.4730
Review panels Gastroenterology & Urology
Registered establishments Medline Canada, Medline Industries, LP - Mexicali (MXC), MEDLINE INDUSTRIES, LP - Northfield, PRODUCTOS MEDLINE S.A. DE C.V.
Establishment registrations 1417592, 3004122598, 3007289408, 3015173212
FEI numbers 1417592, 3004122598, 3007289408, 3015173212
Establishment operations Contract Sterilizer, Foreign Exporter, Repackager/Relabeler, Specification Developer
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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