FDA device listing

Spatula, Ophthalmic

FDA device listing 1373915214 · MEDENNIUM, INC.

Key facts

Owner/operator MEDENNIUM, INC.
Owner/operator number 9040473
Product codes HND
Device names HND - Spatula, Ophthalmic
Device class Class I
Classification regulations (21 CFR) 886.4350
Review panels Ophthalmic
Registered establishments MEDENNIUM, INC.
Establishment registrations 2031959
FEI numbers 3002777043
Establishment operations Repackager/Relabeler, Specification Developer
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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