FDA device listing

GT5 conductive & abrasive gel

FDA device listing 1279805324 · Wuhan Greentek Pty Ltd.

Key facts

Proprietary names GT5 conductive & abrasive gel
Owner/operator Wuhan Greentek Pty Ltd.
Owner/operator number 10071887
Premarket submissions K212787
Product codes GYB
Device names GYB - Media, Electroconductive
Device class Class II
Classification regulations (21 CFR) 882.1275
Review panels Neurology
Registered establishments WUHAN GREENTEK PTY LTD.
Establishment registrations 3010515191
FEI numbers 3010515191
Establishment operations Foreign Exporter, Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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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