FDA device listing

Barraquer Speculum, Solid 18mm Blade (PC),Birks Tying Forceps,Chalazion Curette 2mm,Corneal Epithelium Spatula…

FDA device listing 1134636944 · Beaver-Visitec International, Inc.

Key facts

Proprietary names Barraquer Speculum, Solid 18mm Blade (PC),Birks Tying Forceps,Chalazion Curette 2mm,Corneal Epithelium Spatula, Flat,Epithelium Well,Epithelium Well, 8.5mm,Epithelium Well Trephining,Eye Guard,Fine Toothed Forceps Short (Bonn),IOL Removal Forceps,Iris Scissors Straight, Pointed,Jewellers Forceps Curved/Plain,LASEK Microhoe, (Yee), Formed tip, 12mm from end,LASIK Cap / Flap Elevator…
Owner/operator Beaver-Visitec International, Inc.
Owner/operator number 10033379
Product codes MDM
Device names MDM - Instrument, Manual, Surgical, General Use
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments Beaver-Visitec International, Inc., Beaver-Visitec International, Ltd, Malosa Medical Instruments (Changshu) Limited
Establishment registrations 1211998, 9680620, 3012733432, 3013421458
FEI numbers 1211998, 3002808441, 3012733432, 3013421458
Establishment operations Contract Manufacturer, Manufacturer, 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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