FDA device listing

Bag, Urine Collection, Newborn

FDA device listing 1711892436 · Global Resources International Dominicana GRID S.R.L.

Key facts

Owner/operator Global Resources International Dominicana GRID S.R.L.
Owner/operator number 10080821
Product codes FOC
Device names FOC - Bag, Urine Collection, Newborn
Device class Class II
Classification regulations (21 CFR) 876.5250
Review panels Gastroenterology & Urology
Registered establishments GLOBAL RESOURCES INTERNATIONAL DOMINICANA GRID S.R.L.
Establishment registrations 3018077422
FEI numbers 3018077422
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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