FDA device listing

Surgical Instruments, G-U, Manual (And Accessories)

FDA device listing 1894290789 · Grace Manufacturing Inc

Key facts

Owner/operator Grace Manufacturing Inc
Owner/operator number 10042478
Product codes KOA
Device names KOA - Surgical Instruments, G-U, Manual (And Accessories)
Device class Class I
Classification regulations (21 CFR) 876.4730
Review panels Gastroenterology & Urology
Registered establishments GRACE MANUFACTURING INC
Establishment registrations 1651252
FEI numbers 3002770040
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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