FDA device listing

Lactosorb Water Bath

FDA device listing 1308312070 · BIOMET MICROFIXATION

Key facts

Proprietary names Lactosorb Water Bath
Owner/operator BIOMET MICROFIXATION
Owner/operator number 1032347
Product codes IRQ
Device names IRQ - Unit, Heating, Powered
Device class Class I
Classification regulations (21 CFR) 890.5950
Review panels Physical Medicine
Registered establishments BIOMET MICROFIXATION
Establishment registrations 1032347
FEI numbers 1032347
Establishment operations Repackager/Relabeler, 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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