FDA device listing

Bandage, Cast

FDA device listing 1088222021 · Solventum US LLC

Key facts

Owner/operator Solventum US LLC
Owner/operator number 10091183
Product codes ITG
Device names ITG - Bandage, Cast
Device class Class I
Classification regulations (21 CFR) 890.3025
Review panels Physical Medicine
Registered establishments Solventum Germany GmbH, Solventum Poland Manufacturing SP. ZO.O, Solventum US LLC, SOLVENTUM US LLC
Establishment registrations 3031841433, 3032763783, 3032911850, 3042272797
FEI numbers 3031841433, 3032763783, 3032911850, 3042272797
Establishment operations Complaint File Establishment, Foreign Exporter, Specification Developer, Manufacturer
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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