FDA device listing

Cunningham Woodland, Inc

FDA device listing 1626387356 · CUNNINGHAM WOODLAND, INC.

Key facts

Proprietary names Cunningham Woodland, Inc
Owner/operator CUNNINGHAM WOODLAND, INC.
Owner/operator number 1219659
Premarket submissions K100518
Product codes DWP
Device names DWP - Dilator, Vessel, Surgical
Device class Class II
Classification regulations (21 CFR) 870.4475
Review panels Cardiovascular
Registered establishments CUNNINGHAM WOODLAND, INC.
Establishment registrations 1219659
FEI numbers 1219659
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 100–999 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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