FDA device listing

Protector, Skin Pressure

FDA device listing 1245454299 · Prism Pacific Industries LLC

Key facts

Owner/operator Prism Pacific Industries LLC
Owner/operator number 10087414
Product codes FMP
Device names FMP - Protector, Skin Pressure
Device class Class I
Classification regulations (21 CFR) 880.6450
Review panels General Hospital
Registered establishments PRISM PACIFIC INDUSTRIES LLC
Establishment registrations 3026523692
FEI numbers 3026523692
Establishment operations Complaint File Establishment, Repackager/Relabeler, Reprocessor of Single Use Devices
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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