FDA device listing

Codman Leroy Raney Scalp Bulk,Codman Leroy Raney Scalp Clips,Codman Leroy Scalp Clip Adult,Codman Leroy Scalp Clips…

FDA device listing 1304182435 · Integra LifeSciences Corporation

Key facts

Proprietary names Codman Leroy Raney Scalp Bulk,Codman Leroy Raney Scalp Clips,Codman Leroy Scalp Clip Adult,Codman Leroy Scalp Clips Pediatric,Codman Raney Scalp Clips,Codman Raney Scalp Clips Bulk
Owner/operator Integra LifeSciences Corporation
Owner/operator number 9004007
Product codes HBO
Device names HBO - Clip, Scalp
Device class Class II
Classification regulations (21 CFR) 882.4150
Review panels Neurology
Registered establishments Integra LifeSciences Corporation, Integra LifeSciences Production Corporation, Integra Pain Management
Establishment registrations 1722447, 3003418325, 3014334038
FEI numbers 1000138491, 3003418325, 3014334038
Establishment operations Complaint File Establishment, Manufacturer, 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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