FDA device listing

First ftjd Dressing Bandages

FDA device listing 2038185447 · GAUKE INTERNATIONAL TRADING CO., LTD.

Key facts

Proprietary names First ftjd Dressing Bandages
Owner/operator GAUKE INTERNATIONAL TRADING CO., LTD.
Owner/operator number 10092137
Product codes ITG
Device names ITG - Bandage, Cast
Device class Class I
Classification regulations (21 CFR) 890.3025
Review panels Physical Medicine
Registered establishments GAUKE INTERNATIONAL TRADING CO., LTD.
Establishment registrations 3026263452
FEI numbers 3026263452
Establishment operations Foreign Exporter, 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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