FDA device listing

1000035, 1100050, 1110055, 1111065, 1111570, 1112080, 1113090, 1114100, 1115120,8001000, 8001002, 8002000, 8002001…

FDA device listing 1459989471 · INTERSURGICAL LTD.

Key facts

Proprietary names 1000035, 1100050, 1110055, 1111065, 1111570, 1112080, 1113090, 1114100, 1115120,8001000, 8001002, 8002000, 8002001, 8002002, 8003000, 8003003, 8003050, 8004000,8003001, 8003002, 8004001, 8004002, 8005001, 8005002,8004003, 8004050, 8005000, 8005003, 8005050, 8015000, 8015002,8025000, 8025001, 8025002,8201000, 8202000, 8203000, 8204000, 8205000, 8215000, 8225000, 8603000, 8604000, 8605000,8201030…
Owner/operator INTERSURGICAL LTD.
Owner/operator number 9037658
Product codes CAE
Device names CAE - Airway, Oropharyngeal, Anesthesiology
Device class Class I
Classification regulations (21 CFR) 868.5110
Review panels Anesthesiology
Registered establishments INTERSURGICAL LTD.
Establishment registrations 3002807267
FEI numbers 3002807267
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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