FDA device listing

Electrosurgical, Cutting & Coagulation & Accessories

FDA device listing 1838484767 · Precera Medical Inc

Key facts

Owner/operator Precera Medical Inc
Owner/operator number 10094474
Product codes GEI, LFL
Device names GEI - Electrosurgical, Cutting & Coagulation & Accessories, LFL - Instrument, Ultrasonic Surgical
Device class Class II, Unclassified
Classification regulations (21 CFR) 878.4400, ORCA1.LFL
Review panels General & Plastic Surgery
Registered establishments LISI MEDICAL REmmele
Establishment registrations 3009941480
FEI numbers 3009941480
Establishment operations Contract 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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