FDA device listing

Hu-Friedy Mfg Co.,LLC,MALLET

FDA device listing 1364051487 · Hu-Friedy Mfg Co., LLC

Key facts

Proprietary names Hu-Friedy Mfg Co.,LLC,MALLET
Owner/operator Hu-Friedy Mfg Co., LLC
Owner/operator number 1416605
Product codes HXL
Device names HXL - Mallet
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments HU-FRIEDY MFG CO., LLC, HU-FRIEDY MFG. CO. LLC, HU-FRIEDY MFG.CO. LLC ZWEIGNIEDERLASSUNG DEUTSC
Establishment registrations 1416605, 3004193466, 3009968482
FEI numbers 1416605, 3004193466, 3009968482
Establishment operations Foreign Exporter, Repackager/Relabeler, Manufacturer
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

Browse all FDA device listings