FDA device listing

stryker suction mat (comfort),Stryker Suction ring with tubing,,Styrker suction mat (low profile),Styrker suction ring…

FDA device listing 1583402176 · GRAND RAPIDS FOAM TECHNOLOGIES, INC.

Key facts

Proprietary names stryker suction mat (comfort),Stryker Suction ring with tubing,,Styrker suction mat (low profile),Styrker suction ring without tubing
Owner/operator GRAND RAPIDS FOAM TECHNOLOGIES, INC.
Owner/operator number 9007959
Product codes GCX
Device names GCX - Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device class Class II
Classification regulations (21 CFR) 880.6740
Review panels General Hospital
Registered establishments GRANDRAPIDS FOAM TECHNOLOGIES, INC.
Establishment registrations 1834244
FEI numbers 1000220700
Establishment operations Contract 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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