FDA device listing

Good Vibrations,ProClense Plus,ProClense Plus SCD,Pro E-Vac,Pro EZ 1,Pro EZ 2,Pro EZ AW Quad,Pro EZ Foam,Pro EZ Gel…

FDA device listing 1866359766 · MicroCare, LLC

Key facts

Proprietary names Good Vibrations,ProClense Plus,ProClense Plus SCD,Pro E-Vac,Pro EZ 1,Pro EZ 2,Pro EZ AW Quad,Pro EZ Foam,Pro EZ Gel Pre-Treatment Gel,Pro EZ SCD,ProLube Concentrate,ProLube Ready to Use,ProLube SCD,ProRinse,ProWash,ProWash SCD
Owner/operator MicroCare, LLC
Owner/operator number 10082240
Product codes JCB
Device names JCB - Detergent
Device class Class I
Classification regulations (21 CFR) 864.4010
Review panels Pathology
Registered establishments MicroCare CT - John Downey, MicroCare Medical
Establishment registrations 1720499, 3007268782
FEI numbers 1720499, 3007268782
Establishment operations Manufacturer, Repackager/Relabeler
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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