FDA device listing

BD Single Use Syringe

FDA device listing 1391322515 · MUSCULOSKELETAL TRANSPLANT FOUNDATION

Key facts

Proprietary names BD Single Use Syringe
Owner/operator MUSCULOSKELETAL TRANSPLANT FOUNDATION
Owner/operator number 9032400
Premarket submissions K110771
Product codes FMF
Device names FMF - Syringe, Piston
Device class Class II
Classification regulations (21 CFR) 880.5860
Review panels General Hospital
Registered establishments Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics
Establishment registrations 2249062, 1000307092, 3008812241
FEI numbers 1000307092, 3001236616, 3006813973
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 UDI devices (GUDID) under the same submission
  • 10–99 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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