FDA device listing

Suprapubic Metal Tip Puncture and Drainage Set,Suprapubic Puncture and Drainage Set

FDA device listing 1156461959 · Allwin Medical Devices

Key facts

Proprietary names Suprapubic Metal Tip Puncture and Drainage Set,Suprapubic Puncture and Drainage Set
Owner/operator Allwin Medical Devices
Owner/operator number 9036357
Product codes FBQ
Device names FBQ - Trocar, Gastro-Urology
Device class Class II
Classification regulations (21 CFR) 876.5090
Review panels Gastroenterology & Urology
Registered establishments Allwin Medical Devices Pvt. Ltd.
Establishment registrations 9617744
FEI numbers 3006279007
Establishment operations 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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