FDA device listing

Hollister

FDA device listing 2071886547 · Hollister Inc.

Key facts

Proprietary names Hollister
Owner/operator Hollister Inc.
Owner/operator number 1480288
Product codes GBX
Device names GBX - Catheter, Irrigation
Device class Class I
Classification regulations (21 CFR) 878.4200
Review panels General & Plastic Surgery
Registered establishments HOLLISTER, INC., HOLLISTER INCORPORATED
Establishment registrations 1119193, 1480288, 2320961
FEI numbers 1119193, 1480288, 3003172243
Establishment operations 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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