FDA device listing

DIAMATRIX

FDA device listing 1515479652 · DIAMATRIX LIMITED, INC.

Key facts

Proprietary names DIAMATRIX
Owner/operator DIAMATRIX LIMITED, INC.
Owner/operator number 9041339
Product codes HNY
Device names HNY - Cystotome
Device class Class I
Classification regulations (21 CFR) 886.4350
Review panels Ophthalmic
Registered establishments INTERNATIONAL SCIENCE AND TECHNOLOGY, LP
Establishment registrations 1651405
FEI numbers 3000892087
Establishment operations Repackager/Relabeler
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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