FDA device listing

Pliers, Surgical

FDA device listing 1644961658 · ARTHREX, INC.

Key facts

Proprietary names Pliers, Surgical
Owner/operator ARTHREX, INC.
Owner/operator number 1220287
Product codes HTC
Device names HTC - Pliers, Surgical
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments Arthrex Australia Pty Ltd., Arthrex, Inc., ARTHREX, INC., Arthrex Manufacturing Inc., Arthrex New Zealand Limited
Establishment registrations 1220246, 3010331645, 3015231789, 3019269298, 3020704423
FEI numbers 1220246, 3010331645, 3015231789, 3019269298, 3020704423
Establishment operations Contract Manufacturer, Contract Sterilizer, Foreign Exporter, 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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