FDA device listing

Critical Response,Medline

FDA device listing 1083364668 · Medline Industries, LP

Key facts

Proprietary names Critical Response,Medline
Owner/operator Medline Industries, LP
Owner/operator number 1417592
Product codes JOK
Device names JOK - Scissors, Medical, Disposable
Device class Class I
Classification regulations (21 CFR) 880.6820
Review panels General Hospital
Registered establishments MEDLINE INDUSTRIES, LP - Laredo, Medline Industries, LP - Mexicali (MXC), MEDLINE INDUSTRIES, LP - Northfield, MEDLINE INDUSTRIES, LP (Northpoint Services)
Establishment registrations 1417592, 1422634, 3005595283, 3015173212
FEI numbers 1417592, 1000514656, 3005595283, 3015173212
Establishment operations Contract Sterilizer, Manufacturer, Repackager/Relabeler, Reprocessor of Single Use Devices, 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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