FDA device listing

STC ID Code ND1 ND2 Wrappel Wrappers

FDA device listing 1600010257 · ICAT S.A. de C.V.

Key facts

Proprietary names STC ID Code ND1 ND2 Wrappel Wrappers
Owner/operator ICAT S.A. de C.V.
Owner/operator number 10040106
Product codes FRG
Device names FRG - Wrap, Sterilization
Device class Class II
Classification regulations (21 CFR) 880.6850
Review panels General Hospital
Registered establishments ICAT S.A. DE C.V., Vidales Larranaga SA de CV
Establishment registrations 3005748481, 3011497662
FEI numbers 3005748481, 3011497662
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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