FDA device listing

MINIACE

FDA device listing 1008364040 · STERILIZATION SERVICES OF GEORGIA, INC.

Key facts

Proprietary names MINIACE
Owner/operator STERILIZATION SERVICES OF GEORGIA, INC.
Owner/operator number 9002392
Product codes EXD, KNT
Device names EXD - Irrigator, Ostomy, KNT - Tubes, Gastrointestinal (And Accessories)
Device class Class II
Classification regulations (21 CFR) 876.5895, 876.5980
Review panels Gastroenterology & Urology
Registered establishments STERILIZATION SERVICES OF GEORGIA, INC.
Establishment registrations 1048735
FEI numbers 1048735
Establishment operations Contract Sterilizer
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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