FDA device listing

Plug, Scleral

FDA device listing 1053551914 · Medicar Health Inc.

Key facts

Owner/operator Medicar Health Inc.
Owner/operator number 10043820
Product codes LXP
Device names LXP - Plug, Scleral
Device class Class II
Classification regulations (21 CFR) 886.4155
Review panels Ophthalmic
Registered establishments MANUFACTURAS Y SERVICIOS INTERNACIONALES, S. DE R.L., RM Healthcare Products SA de CV
Establishment registrations 3008692839, 3029973819
FEI numbers 3008692839, 3029973819
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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