Home GUDID H965100321 Exodus
Primary DI H965100321
Brand Exodus
Company NAVILYST MEDICAL, INC.
Model 10032
Device description 10F x 35cm Standard Loop Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
Published 2015-09-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GBO Catheter, Nephrostomy, General & Plastic Surgery General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status H965100321 Package HIBCC 5 In Commercial Distribution H965100320 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Closed-wound drain A sterile, tube-like device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a wide variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, and general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp metal trocar, connector), however it does not include any fluid collection bags/containers. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 10 French Length 35 Centimeter Outer Diameter 3.4 Millimeter
Regulatory Flags# DUNS number 809699023 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 15051684011587 Total Abscession Angiodynamics, Inc. GBO 2024-10-30 15051684011594 Total Abscession Angiodynamics, Inc. GBO 2024-10-30 15051684011600 Total Abscession Angiodynamics, Inc. GBO 2024-10-30 15051684011617 Total Abscession Angiodynamics, Inc. GBO 2024-10-30 15051684011624 Total Abscession Angiodynamics, Inc. GBO 2024-10-30 15051684011631 Total Abscession Angiodynamics, Inc. GBO 2024-10-30 15051684011648 Total Abscession Angiodynamics, Inc. GBO 2024-10-30 15051684011655 Total Abscession Angiodynamics, Inc. GBO 2024-10-30 15051684011662 Total Abscession Angiodynamics, Inc. GBO 2024-10-30 00812261011806 allDrain ALLWIN MEDICAL DEVICES, INC. GBO 2024-01-09 00812261012308 allDrain ALLWIN MEDICAL DEVICES, INC. GBO 2024-01-09 00812261012315 allDrain ALLWIN MEDICAL DEVICES, INC. GBO 2024-01-09 00812261019222 allDrain ALLWIN MEDICAL DEVICES, INC. GBO 2024-01-09 00812261012292 allDrain ALLWIN MEDICAL DEVICES, INC. GBO 2024-01-08 00812261012285 allDrain ALLWIN MEDICAL DEVICES, INC. GBO 2023-07-28 00817640020103 Aspiration and Flush Assembly URESIL, LLC GBO 2022-05-19 00817640020110 Aspiration and Flush Assembly URESIL, LLC GBO 2022-05-19 00817640020202 Aspiration and Flush Assembly URESIL, LLC GBO 2022-05-19 00817640020097 GP General Purpose Drainage Catheter URESIL, LLC GBO 2022-04-29 00817640020219 GP General Purpose Drainage Catheter URESIL, LLC GBO 2022-04-29 00817640020035 GP General Purpose Drainage Catheter URESIL, LLC GBO 2022-04-28 00817640020042 GP General Purpose Drainage Catheter URESIL, LLC GBO 2022-04-28 00817640020066 GP General Purpose Drainage Catheter URESIL, LLC GBO 2022-04-28 00817640020073 GP General Purpose Drainage Catheter URESIL, LLC GBO 2022-04-28 00817640020080 GP General Purpose Drainage Catheter URESIL, LLC GBO 2022-04-28 00817640020059 GP General Purpose Drainage Catheter URESIL, LLC GBO 2022-04-26 H862MPL2T1230H0 GP General Purpose Drainage Catheter URESIL, LLC GBO 2021-06-10 H862MPLT21430H0 GP General Purpose Drainage Catheter URESIL, LLC GBO 2021-06-10 H862GPJT0620H0 GP General Purpose Drainage Catheter URESIL, LLC GBO 2021-06-09 H862GPJT0825H0 GP General Purpose Drainage Catheter URESIL, LLC GBO 2021-06-09
angiodynamics.com