FDA device listing

Plasters

FDA device listing 1477463935 · Detectamet INC

Key facts

Proprietary names Plasters
Owner/operator Detectamet INC
Owner/operator number 10056399
Product codes KGX
Device names KGX - Tape And Bandage, Adhesive
Device class Class I
Classification regulations (21 CFR) 880.5240
Review panels General Hospital
Registered establishments DETECTAMET INC
Establishment registrations 3011631224
FEI numbers 3011631224
Establishment operations 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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