Home GUDID B382SD501011SM46 Surgical Direct
Primary DI B382SD501011SM46
Brand Surgical Direct
Company Surgical Direct, Inc.
Model SD50-1011SM-46
Catalog number SD50-1011SM-46
Device description 4mm 46cm Catheter Passer, Shunt Guide with Hole in Tip, T-Handle
Published 2026-08-03
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name PIY Stainless Steel Instrument, Shunt System Implantation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PIY Stainless Steel Instrument, Shunt System Implantation Neurology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B382SD501011SM46 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Vascular graft tunneller A long, surgical instrument used to tunnel an artificial passageway along vascular tissue planes to create a connecting channel typically for the introduction of a vascular graft or a vascular prosthesis. It can have a variety of designs, but basically it will be a long, round, stiff rod that tapers to a rounded point at the distal tip and have a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue. It will typically be made of high-grade stainless steel and possibly other materials for the handle, which may be detachable. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 124367223 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00190776422479 Millennium Avalign Technologies, Inc. PIY 2026-07-31 00198506090875 ELMED INCORPORATED ELMED INCORPORATED PIY 2026-05-18 00190776421007 Millennium Avalign Technologies, Inc. PIY 2026-04-30 00190776410841 Millennium Avalign Technologies, Inc. PIY 2025-09-12 00190776410858 Millennium Avalign Technologies, Inc. PIY 2025-09-12 00198506085062 ELMED INCORPORATED ELMED INCORPORATED PIY 2025-09-05 00190776401900 Millennium Avalign Technologies, Inc. PIY 2025-06-16 00198506082917 ELMED INCORPORATED ELMED INCORPORATED PIY 2025-05-22 00190776395957 Millennium Avalign Technologies, Inc. PIY 2025-05-09 00198506082511 ELMED INCORPORATED ELMED INCORPORATED PIY 2025-04-30 00198506081958 ELMED INCORPORATED ELMED INCORPORATED PIY 2025-04-07 00198506075469 ELMED INCORPORATED ELMED INCORPORATED PIY 2025-02-20 00190776389215 Millennium Avalign Technologies, Inc. PIY 2024-11-15 00198506061325 ELMED INCORPORATED ELMED INCORPORATED PIY 2024-09-11 00198506061110 ELMED INCORPORATED ELMED INCORPORATED PIY 2024-09-05 00842180199408 ELMED ELMED INCORPORATED PIY 2024-04-23 00842180199415 ELMED ELMED INCORPORATED PIY 2024-04-23 00842180199422 ELMED ELMED INCORPORATED PIY 2024-04-23 00842180199446 ELMED ELMED INCORPORATED PIY 2024-04-23 00842180199453 ELMED ELMED INCORPORATED PIY 2024-04-23 00842180197732 ELMED ELMED INCORPORATED PIY 2024-04-18 00842180192096 ELMED ELMED INCORPORATED PIY 2024-04-16 00842180192102 ELMED ELMED INCORPORATED PIY 2024-04-16 00842180187382 ELMED ELMED INCORPORATED PIY 2024-03-06 00190776299484 Millennium Avalign Technologies, Inc. PIY 2023-11-15 00190776300630 Millennium Avalign Technologies, Inc. PIY 2023-11-15 00190776301088 Millennium Avalign Technologies, Inc. PIY 2023-11-15 00190776376123 Millennium Avalign Technologies, Inc. PIY 2023-09-08 00842180175624 ELMED ELMED INCORPORATED PIY 2023-08-08 00842180175631 ELMED ELMED INCORPORATED PIY 2023-08-08
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