FDA device listing

Electrosurgical, Cutting & Coagulation & Accessories

FDA device listing 1404464794 · Dynamic Diagnostics Incorporated

Key facts

Owner/operator Dynamic Diagnostics Incorporated
Owner/operator number 10044579
Premarket submissions K143103
Product codes GEI
Device names GEI - Electrosurgical, Cutting & Coagulation & Accessories
Device class Class II
Classification regulations (21 CFR) 878.4400
Review panels General & Plastic Surgery
Registered establishments DYNAMIC DIAGNOSTICS INCORPORATED
Establishment registrations 3010230734
FEI numbers 3010230734
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
  • 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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