FDA device listing

RONGEUR

FDA device listing 2066098196 · Melpex Beauty Instruments

Key facts

Proprietary names RONGEUR
Owner/operator Melpex Beauty Instruments
Owner/operator number 10036390
Product codes HTX
Device names HTX - Rongeur
Device class Class I
Classification regulations (21 CFR) 888.4540
Review panels Orthopedic
Registered establishments MELPEX BEAUTY INSTRUMENTS
Establishment registrations 3005092287
FEI numbers 3005092287
Establishment operations 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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