FDA device listing

STERILE EQUIPMENT COVER

FDA device listing 2027570939 · MEDXL

Key facts

Proprietary names STERILE EQUIPMENT COVER
Owner/operator MEDXL
Owner/operator number 10089418
Product codes KKX
Device names KKX - Drape, Surgical, Antimicrobial
Device class Class II
Classification regulations (21 CFR) 878.4370
Review panels General & Plastic Surgery
Registered establishments MedXL
Establishment registrations 1644312
FEI numbers 1000117748
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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