FDA device listing

Artho-Lok Handle and Wrench 4mm,Barron Scalpel Handle Flat,Beaver BeaverTail Flat Handle,Beaver Blade Wrench,Beaver…

FDA device listing 1253488487 · Beaver-Visitec International, Inc.

Key facts

Proprietary names Artho-Lok Handle and Wrench 4mm,Barron Scalpel Handle Flat,Beaver BeaverTail Flat Handle,Beaver Blade Wrench,Beaver Handle,Beaver Handle (Round Knurled Stainless),Beaver Replacement Chuck Collet,Dynagrip Handle and Wrench 4mm,Lens Handle,Scalpel Blade Handle With Gradations
Owner/operator Beaver-Visitec International, Inc.
Owner/operator number 10033379
Product codes GDZ
Device names GDZ - Handle, Scalpel
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, Grupo American Industries, S.A. de C.V, Malosa Medical Instruments (Changshu) Limited
Establishment registrations 1211998, 9680620, 3012733432, 3013421458, 3013466775
FEI numbers 1211998, 3002808441, 3012733432, 3013421458, 3013466775
Establishment operations Contract Manufacturer, Foreign Exporter, 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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