Home GUDID 00190776055868 Avalign
Primary DI 00190776055868
Brand Avalign
Company Avalign Technologies, Inc.
Model VM77-2662
Device description Rumel Tourniquet, flex-neck,
Published 2021-11-03
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true 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 00190776055868 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 00190776055868 00190776055868 190776055868 0190776055868
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 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 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 M2743054981 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION EYR 2018-03-02
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