FDA device listing

Beveled Degree Gauge,Bores OZ Marker,Fine-Thornton swivel fixation ring,Mendez degree gauge,Thornton Fixation Ring,Toric…

FDA device listing 1321641554 · medetz surgical instruments

Key facts

Proprietary names Beveled Degree Gauge,Bores OZ Marker,Fine-Thornton swivel fixation ring,Mendez degree gauge,Thornton Fixation Ring,Toric IOL Reference Marker
Owner/operator medetz surgical instruments
Owner/operator number 10059883
Product codes HMR
Device names HMR - Marker, Ocular
Device class Class I
Classification regulations (21 CFR) 886.4570
Review panels Ophthalmic
Registered establishments MEDETZ SURGICAL INSTRUMENTS
Establishment registrations 3006380247
FEI numbers 3006380247
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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