FDA device listing

Disposable Shoe Covers

FDA device listing 1115856249 · Arrow Medsource Group Limited

Key facts

Proprietary names Disposable Shoe Covers
Owner/operator Arrow Medsource Group Limited
Owner/operator number 10064458
Product codes BWP
Device names BWP - Shoe And Shoe Cover, Conductive
Device class Class I
Classification regulations (21 CFR) 878.4040
Review panels General & Plastic Surgery
Registered establishments ARROW MEDSOURCE GROUP LIMITED
Establishment registrations 3016685880
FEI numbers 3016685880
Establishment operations Foreign Exporter, 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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