Home GUDID 00190776420321 Millennium
Primary DI 00190776420321
Brand Millennium
Company Avalign Technologies, Inc.
Model 85-50005878
Device description Rumel Tourniquet, obturator only
Published 2026-08-25
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 EYR Tourniquet, Gastro-Urology
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EYR Tourniquet, Gastro-Urology General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190776420321 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 00190776420321 00190776420321 190776420321 0190776420321
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 00887482043622 Symmetry Rumel ASPEN SURGICAL PRODUCTS, INC. EYR 2024-08-12 00887482083857 Symmetry Rumel ASPEN SURGICAL PRODUCTS, INC. EYR 2024-08-12 00190776290498 MILLENNIUM Avalign Technologies, Inc. EYR 2023-09-28 00190776334734 MILLENNIUM Avalign Technologies, Inc. EYR 2023-09-28 00190776370060 MILLENNIUM Avalign Technologies, Inc. EYR 2023-09-28 14026704795670 PILLING TELEFLEX INCORPORATED EYR 2022-12-08 14026704795694 PILLING TELEFLEX INCORPORATED EYR 2022-12-08 54026704795678 PILLING TELEFLEX INCORPORATED EYR 2022-12-08 14026704795700 PILLING TELEFLEX INCORPORATED EYR 2022-12-08 14026704795687 PILLING TELEFLEX INCORPORATED EYR 2022-12-08 54026704795692 PILLING TELEFLEX INCORPORATED EYR 2022-12-08 00190776055837 Avalign Avalign Technologies, Inc. EYR 2021-11-03 00190776055844 Avalign Avalign Technologies, Inc. EYR 2021-11-03 00190776055868 Avalign Avalign Technologies, Inc. EYR 2021-11-03 00190776055875 Avalign Avalign Technologies, Inc. EYR 2021-11-03 00190776055882 Avalign Avalign Technologies, Inc. EYR 2021-11-03 00190660111786 Ambler Surgical AMBLER SURGICAL CORP. EYR 2021-01-07 00190660111793 Ambler Surgical AMBLER SURGICAL CORP. EYR 2021-01-07 00190660111809 Ambler Surgical AMBLER SURGICAL CORP. EYR 2021-01-07 00190660111816 Ambler Surgical AMBLER SURGICAL CORP. EYR 2021-01-07 00190660111823 Ambler Surgical AMBLER SURGICAL CORP. EYR 2021-01-07 00190660111830 Ambler Surgical AMBLER SURGICAL CORP. EYR 2021-01-07 00190660111847 Ambler Surgical AMBLER SURGICAL CORP. EYR 2021-01-07 00190660111854 Ambler Surgical AMBLER SURGICAL CORP. EYR 2021-01-07 10381780191018 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION EYR 2018-03-02 10381780191025 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION EYR 2018-03-02 10381780457862 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION EYR 2018-03-02 10381780457879 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION EYR 2018-03-02 M2743055001 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION EYR 2018-03-02 M2743055011 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION EYR 2018-03-02
avalign.com