Home GUDID 25051684011607
Total Abscession
Primary DI 25051684011607
Brand Total Abscession
Company Angiodynamics, Inc.
Model 14001003
Device description 10F x 30cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
Published 2024-10-30
Public version status New
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 25051684011607 Package GS1 5 In Commercial Distribution H787140010030 Previous HIBCC 0 15051684011600 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 25051684011607 25051684011607 15051684011600 15051684011600
GMDN Terms# Term, Definition table Term Definition Nephrostomy catheter A sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. It is used to perform drainage for relief of supravesicular obstructions and may also be intended for a variety of procedures of the upper urinary tract including dilation of strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones, or ureteral stenting. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 10 French Length 30 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 27 Degrees Celsius
Regulatory Flags# DUNS number 079252781 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 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