FDA device listing

General and Plastic Surgery Catheter Adaptor

FDA device listing 1054183296 · Hexamed Pvt Ltd

Key facts

Proprietary names General and Plastic Surgery Catheter Adaptor
Owner/operator Hexamed Pvt Ltd
Owner/operator number 10095463
Product codes GCE
Device names GCE - Adaptor, Catheter
Device class Class I
Classification regulations (21 CFR) 878.4200
Review panels General & Plastic Surgery
Registered establishments HEXAMED PVT LTD
Establishment registrations 3032747418
FEI numbers 3032747418
Establishment operations Contract Manufacturer, Manufacturer
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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