FDA device listing

Medline Convenience Trays & Kits CSTM,Medline Double / Single Basin Trays,Medline Laceration Tray,Medline surgical…

FDA device listing 2063871520 · Medline Industries, LP

Key facts

Proprietary names Medline Convenience Trays & Kits CSTM,Medline Double / Single Basin Trays,Medline Laceration Tray,Medline surgical kits/trays and CDS modules,Medline Surgical Shave Prep Tray,Medline UNITE Joint Prep Kit
Owner/operator Medline Industries, LP
Owner/operator number 1417592
Product codes KDD
Device names KDD - Kit, Surgical Instrument, Disposable
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), MEDLINE INDUSTRIES, LP - SPT, Medline Soluciones Medicas, Nuevo Laredo Directo al Cliente, PRODUCTOS MEDLINE S.A. DE C.V.
Establishment registrations 1417592, 1422634, 1423395, 3004122598, 3005595283, 3015173212, 3045816902, 3045816907
FEI numbers 1417592, 1000514656, 3000717925, 3004122598, 3005595283, 3015173212, 3045816902, 3045816907
Establishment operations Complaint File Establishment, Specification Developer, 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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