FDA device listing

Katena

FDA device listing 1490866900 · SDI SURGICAL DEVICE INTERNATIONAL GMBH

Key facts

Proprietary names Katena
Owner/operator SDI SURGICAL DEVICE INTERNATIONAL GMBH
Owner/operator number 9096119
Product codes MSS
Device names MSS - Folders And Injectors, Intraocular Lens (Iol)
Device class Class I
Classification regulations (21 CFR) 886.4300
Review panels Ophthalmic
Registered establishments SDI SURGICAL DEVICE INTERNATIONAL GMBH
Establishment registrations 3006234591
FEI numbers 3006234591
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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