FDA device listing

Tourniquet

FDA device listing 1646023253 · Ningbo Jenius Medical Tech Co., Ltd.

Key facts

Proprietary names Tourniquet
Owner/operator Ningbo Jenius Medical Tech Co., Ltd.
Owner/operator number 10044264
Product codes GAX
Device names GAX - Tourniquet, Nonpneumatic
Device class Class I
Classification regulations (21 CFR) 878.5900
Review panels General & Plastic Surgery
Registered establishments NINGBO JENIUS POLYMER SCI-TECH CO., LTD
Establishment registrations 3010374920
FEI numbers 3010374920
Establishment operations Manufacturer
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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