FDA device listing

Sterile Cotton Tipped Applicator, Disposable Sampling Swab

FDA device listing 1954065401 · GFA Production Inc

Key facts

Proprietary names Sterile Cotton Tipped Applicator, Disposable Sampling Swab
Owner/operator GFA Production Inc
Owner/operator number 10096048
Product codes KXG
Device names KXG - Applicator, Absorbent Tipped, Sterile
Device class Class I
Classification regulations (21 CFR) 880.6025
Review panels General Hospital
Registered establishments GFA PRODUCTION INC
Establishment registrations 3045526618
FEI numbers 3045526618
Establishment operations 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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