Home GUDID 00190776376123 Millennium
Primary DI 00190776376123
Brand Millennium
Company Avalign Technologies, Inc.
Model 72-2317169801
Device description Neuro Shunt Passer Sleeve 97cm
Published 2023-09-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 00190776376123 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 00190776376123 00190776376123 190776376123 0190776376123
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 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 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 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 00842180175624 ELMED ELMED INCORPORATED PIY 2023-08-08 00842180175631 ELMED ELMED INCORPORATED PIY 2023-08-08 00842180163546 ELMED ELMED INCORPORATED PIY 2023-04-06 00842180164826 ELMED ELMED INCORPORATED PIY 2023-03-10 00842180164833 ELMED ELMED INCORPORATED PIY 2023-03-10 00842180161887 ELMED ELMED INCORPORATED PIY 2023-03-01 00190776209780 Millennium AVALIGN TECHNOLOGIES, INC. PIY 2021-11-02
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