FDA device listing

Gown, examination

FDA device listing 1032848705 · Transparent Supply Solutions Ltd.

Key facts

Proprietary names Gown, examination
Owner/operator Transparent Supply Solutions Ltd.
Owner/operator number 10093601
Product codes FME
Device names FME - Gown, Examination
Device class Class I
Classification regulations (21 CFR) 880.6265
Review panels General Hospital
Registered establishments TRANSPARENT SUPPLY SOLUTIONS LTD.
Establishment registrations 3038772401
FEI numbers 3038772401
Establishment operations 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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