FDA device listing

Medline/Konig Hook, Surgical, General & Plastic Surgery

FDA device listing 1316323513 · Medline Industries, LP

Key facts

Proprietary names Medline/Konig Hook, Surgical, General & Plastic Surgery
Owner/operator Medline Industries, LP
Owner/operator number 1417592
Product codes GDG
Device names GDG - Hook, Surgical, General & Plastic Surgery
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments MEDLINE INDUSTRIES, LP - Laredo, Medline Industries, LP - Mexicali (MXC), MEDLINE INDUSTRIES, LP - Northfield, MEDLINE INDUSTRIES, LP (Northpoint Services)
Establishment registrations 1417592, 1422634, 3005595283, 3015173212
FEI numbers 1417592, 1000514656, 3005595283, 3015173212
Establishment operations Contract Sterilizer, Manufacturer, Repackager/Relabeler, Reprocessor of Single Use Devices, 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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