UDI device identifier

One-Piece/Tuohy-Borst Introducer Tray 497455

UDI device identifier 00886333214631 · ARGON MEDICAL DEVICES, INC.

Key facts

Primary DI 00886333214631
Brand name One-Piece/Tuohy-Borst Introducer Tray
Version or model 497455
Catalog number 497455
Company ARGON MEDICAL DEVICES, INC.
DUNS number 140727624
Product code DRE
GMDN term Vascular catheter introduction set, nonimplantable
Premarket submission K780126
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Sep 16, 2016
Version date May 11, 2026
Description One-Piece/Tuohy-Borst Introducer Tray 8.5F

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 1,000+ GUDID devices with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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