FDA device listing

TUNNELER, BLUNT, BARBED.

FDA device listing 1531502930 · Turnxon Precision Co., Ltd

Key facts

Proprietary names TUNNELER, BLUNT, BARBED.
Owner/operator Turnxon Precision Co., Ltd
Owner/operator number 10048717
Product codes LFJ
Device names LFJ - Catheter, Subclavian
Device class Class II
Classification regulations (21 CFR) 876.5540
Review panels Gastroenterology & Urology
Registered establishments TURNXON PRECISION CO., LTD
Establishment registrations 3011534620
FEI numbers 3011534620
Establishment operations Contract 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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