FDA device listing

Integra,Mayfield Base Unit,MicroFrance

FDA device listing 1442802373 · Integra LifeSciences Corporation

Key facts

Proprietary names Integra,Mayfield Base Unit,MicroFrance
Owner/operator Integra LifeSciences Corporation
Owner/operator number 9004007
Product codes BWN
Device names BWN - Table And Attachments, Operating-Room
Device class Class I
Classification regulations (21 CFR) 878.4950
Review panels General & Plastic Surgery
Registered establishments Integra LifeSciences Corporation, INTEGRA LIFESCIENCES CORPORATION, Integra LifeSciences Production Corporation, Integra Pain Management, Jarit GmbH
Establishment registrations 1722447, 3003418325, 3004608878, 3005809810, 3014334038
FEI numbers 1000138491, 3003418325, 3004608878, 3005809810, 3014334038
Establishment operations Complaint File Establishment, Manufacturer, 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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