FDA device listing

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

FDA device listing 2064928292 · Aesculap AG

Key facts

Owner/operator Aesculap AG
Owner/operator number 8010193
Premarket submissions K073168
Product codes KCT
Device names KCT - Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device class Class II
Classification regulations (21 CFR) 880.6850
Review panels General Hospital
Registered establishments AESCULAP AG
Establishment registrations 9610612
FEI numbers 3002806315
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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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