FDA device listing

0250-070-500 Suction Irrigator 2,0250-070-520 StrykeFlow 2 With Tip,Neptune Bronze,STRYKER SUCTION…

FDA device listing 1767587322 · STRYKER CORP.

Key facts

Proprietary names 0250-070-500 Suction Irrigator 2,0250-070-520 StrykeFlow 2 With Tip,Neptune Bronze,STRYKER SUCTION IRRIGATOR,Strykevac,SUCTION MAT,Suction Mat, Comfort,50"X34",SUCTION MAT,LOW PROFILE50"X34",SUCTION RING,SUCTION RING WITHOUT TUBING,SUCTION RING WITH TUBING,WALL SUCTION KIT - CBC
Owner/operator STRYKER CORP.
Owner/operator number 1811755
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 STRYKER ENDOSCOPY, Stryker Instruments, STRYKER LEIBINGER GMBH & CO. KG, STRYKER PUERTO RICO, LLC.
Establishment registrations 2648666, 2936485, 8010177, 3015967359
FEI numbers 2648666, 2936485, 3002821504, 3015967359
Establishment operations Complaint File Establishment, Manufacturer, 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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