Home GUDID 03600040325148 Porges Coloplast
Primary DI 03600040325148
Brand Porges Coloplast
Company Coloplast A/S
Model BD4045
Catalog number BD4045
Device description In-Ka Ureteral Balloon Dilatation Catheter + Inflation device (manometer) Balloon Dilation with inflation device, diameter of the balloon 5 mm, body tube length 75 cm, radiopaque stainless-steel rings + inflation device
Published 2020-06-19
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 EZN DILATOR, CATHETER, URETERAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EZN Dilator, Catheter, Ureteral Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03600040325148 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03600040325148 03600040325148 3600040325148
GMDN Terms# Term, Definition table Term Definition Endoscopic-access dilator, single-use A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 5 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store away from light in a cool and dry place
Regulatory Flags# DUNS number 305524696 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 true 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 03600040975336 Coloplast Coloplast A/S EZN 2024-07-09 03600040975367 Coloplast Coloplast A/S EZN 2024-07-09 03600040911068 Coloplast Coloplast A/S EZN 2024-05-21 03600040911105 Coloplast Coloplast A/S EZN 2024-05-21 03600040953808 Coloplast Coloplast A/S EZN 2024-05-21 03600040953785 Coloplast Coloplast A/S EZN 2024-05-10 03600040953693 Coloplast Coloplast A/S EZN 2024-04-12 03600040953716 Coloplast Coloplast A/S EZN 2024-04-12 03600040953747 Coloplast Coloplast A/S EZN 2024-04-12 10812261012602 ARMADA ALLWIN MEDICAL DEVICES, INC. EZN 2023-07-31 10812261012619 ARMADA ALLWIN MEDICAL DEVICES, INC. EZN 2023-07-31 03600040325117 Porges Coloplast Coloplast A/S EZN 2020-06-19 03600040325179 Porges Coloplast Coloplast A/S EZN 2020-06-19 05708932727501 Porges Coloplast Coloplast A/S EZN 2020-06-19 05708932727532 Porges Coloplast Coloplast A/S EZN 2020-06-19 05708932727563 Porges Coloplast Coloplast A/S EZN 2020-06-19 00810116021383 Dornier MedTech DORNIER MEDTECH AMERICA, INC. EZN 2020-02-25 00810116021390 Dornier MedTech DORNIER MEDTECH AMERICA, INC. EZN 2020-02-25 00810116021406 Dornier MedTech DORNIER MEDTECH AMERICA, INC. EZN 2020-02-25 00810116021413 Dornier MedTech DORNIER MEDTECH AMERICA, INC. EZN 2020-02-25 00810116021420 Dornier MedTech DORNIER MEDTECH AMERICA, INC. EZN 2020-02-25 00810116021437 Dornier MedTech DORNIER MEDTECH AMERICA, INC. EZN 2020-02-25 00810116021444 Dornier MedTech DORNIER MEDTECH AMERICA, INC. EZN 2020-02-25 00810116021451 Dornier MedTech DORNIER MEDTECH AMERICA, INC. EZN 2020-02-25 00810116021468 Dornier MedTech DORNIER MEDTECH AMERICA, INC. EZN 2020-02-25 00810116021475 Dornier MedTech DORNIER MEDTECH AMERICA, INC. EZN 2020-02-25 00810116021482 Dornier MedTech DORNIER MEDTECH AMERICA, INC. EZN 2020-02-25 00810116021499 Dornier MedTech DORNIER MEDTECH AMERICA, INC. EZN 2020-02-25 00827002150102 Cook 810 COOK INCORPORATED EZN 2019-11-27 00827002150799 Cook 810 COOK INCORPORATED EZN 2019-11-26