FDA device listing

Container

FDA device listing 1038953879 · Medtronic, Inc.

Key facts

Proprietary names Container
Owner/operator Medtronic, Inc.
Owner/operator number 2112641
Product codes FMH
Device names FMH - Container, Specimen, Sterile
Device class Class I
Classification regulations (21 CFR) 864.3250
Review panels Pathology
Registered establishments Medtronic Engineering and Innovation Center (MEIC), Medtronic Mexico S. de R.L. de CV, MEDTRONIC PERFUSION SYSTEMS, MEDTRONIC SOFAMOR DANEK USA, INC., MEDTRONIC XOMED, INC.
Establishment registrations 1030489, 1045254, 2184009, 9617601, 3003120897, 3018094310
FEI numbers 1045254, 1000116158, 1000477302, 3002534070, 3003120897, 3018094310
Establishment operations Complaint File Establishment, Manufacturer, Specification Developer
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

Browse all FDA device listings