FDA device listing

Integra,MicroFrance

FDA device listing 1704039002 · Integra LifeSciences Corporation

Key facts

Proprietary names Integra,MicroFrance
Owner/operator Integra LifeSciences Corporation
Owner/operator number 9004007
Product codes KAY
Device names KAY - Punch, Nasal
Device class Class I
Classification regulations (21 CFR) 874.4420
Review panels Ear, Nose, & Throat
Registered establishments Integra Canada ULC, Integra LifeSciences Corporation, INTEGRA LIFESCIENCES CORPORATION, Integra LifeSciences Production Corporation, INTEGRA MICROFRANCE SAS, Jarit GmbH
Establishment registrations 9680837, 3003418325, 3004608878, 3005809810, 3012507533, 3014334038
FEI numbers 3003249645, 3003418325, 3004608878, 3005809810, 3012507533, 3014334038
Establishment operations Complaint File Establishment, Foreign Exporter, 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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