FDA device listing

Introcan Safety 2 (multi)

FDA device listing 2056364659 · B. BRAUN MELSUNGEN AG

Key facts

Proprietary names Introcan Safety 2 (multi)
Owner/operator B. BRAUN MELSUNGEN AG
Owner/operator number 8010484
Premarket submissions K220756
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 B. BRAUN MELSUNGEN AG
Establishment registrations 9610825
FEI numbers 3002806469
Establishment operations Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 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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