FDA device listing

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

FDA device listing 1340780341 · Khtp Sterilisation Services Sdn. Bhd.

Key facts

Owner/operator Khtp Sterilisation Services Sdn. Bhd.
Owner/operator number 10085005
Product codes FOZ
Device names FOZ - Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class Class II
Classification regulations (21 CFR) 880.5200
Review panels General Hospital
Registered establishments KHTP STERILISATION SERVICES SDN. BHD.
Establishment registrations 3022518300
FEI numbers 3022518300
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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