Home GUDID 00190776395957 Millennium
Primary DI 00190776395957
Brand Millennium
Company Avalign Technologies, Inc.
Model 72-25101146
Device description Neuro Shunt Guide, 46cm x 4mm dia, with hole in tip
Published 2025-05-09
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information 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 00190776395957 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00190776395957 00190776395957 190776395957 0190776395957
GMDN Terms# Term, Definition table Term Definition Subcutaneous tunneller, reusable A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt, retinal chip). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 792528510 Device count 1 Premarket exempt true Lot or batch true 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 B382SD501011SM46 Surgical Direct Surgical Direct, Inc. PIY 2026-08-03 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 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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