FDA device listing

Fogarty

FDA device listing 1646268885 · Becton, Dickinson and Company

Key facts

Proprietary names Fogarty
Owner/operator Becton, Dickinson and Company
Owner/operator number 10093301
Product codes GDJ
Device names GDJ - Clamp, Surgical, General & Plastic Surgery
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments BECTON, DICKINSON AND COMPANY, CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG, EDWARDS LIFESCIENCES TECHNOLOGY SARL
Establishment registrations 2648045, 9615817, 3032916632
FEI numbers 2648045, 3003081151, 3032916632
Establishment operations 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

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