FDA device listing

FEMORAL AIMER HANDLE,UNIVERSAL RATCHET HANDLE

FDA device listing 2053210527 · Celestica de Monterrey S.A. de C.V.

Key facts

Proprietary names FEMORAL AIMER HANDLE,UNIVERSAL RATCHET HANDLE
Owner/operator Celestica de Monterrey S.A. de C.V.
Owner/operator number 10054863
Product codes MDM
Device names MDM - Instrument, Manual, Surgical, General Use
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments CELESTICA de MONTERREY S.A. de C.V.
Establishment registrations 3003139373
FEI numbers 3003139373
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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