FDA device listing

Cutter, Surgical

FDA device listing 1487000719 · JAI SURGICALS LTD.

Key facts

Owner/operator JAI SURGICALS LTD.
Owner/operator number 9005214
Product codes FZT
Device names FZT - Cutter, Surgical
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments JAI SURGICALS LTD.
Establishment registrations 8044030
FEI numbers 3009995358
Establishment operations Contract Manufacturer, Foreign Exporter, Manufacturer, Repackager/Relabeler
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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