Home GUDID 00630094183107 Bioseal Inc.
Primary DI 00630094183107
Brand Bioseal Inc.
Company BIOSEAL
Model 18310/50
Device description Catheter 5Fr
Published 2023-10-05
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name GBX CATHETER, IRRIGATION
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GBX Catheter, Irrigation General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10630094183104 Package GS1 50 In Commercial Distribution 00630094183107 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 10630094183104 10630094183104 00630094183107 00630094183107 630094183107 0630094183107
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.
Regulatory Flags# DUNS number 186968939 Device count 1 DM exempt true Premarket exempt true Lot or batch true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00884450022146 One-Step™ Merit Medical Systems, Inc. GBX 2026-07-29 00884450022160 One-Step™ Merit Medical Systems, Inc. GBX 2026-07-29 00884450022184 One-Step™ Merit Medical Systems, Inc. GBX 2026-07-29 00884450022306 One-Step™ Merit Medical Systems, Inc. GBX 2026-07-29 00884450022313 One-Step™ Merit Medical Systems, Inc. GBX 2026-07-29 00884450022535 One-Step™ Merit Medical Systems, Inc. GBX 2026-07-29 00884450022559 One-Step™ Merit Medical Systems, Inc. GBX 2026-07-29 00884450022566 One-Step™ Merit Medical Systems, Inc. GBX 2026-07-29 00884450022573 One-Step™ Merit Medical Systems, Inc. GBX 2026-07-29 00884450022597 One-Step™ Merit Medical Systems, Inc. GBX 2026-07-29 00884450022603 One-Step™ Merit Medical Systems, Inc. GBX 2026-07-29 00884450022665 One-Step™ Merit Medical Systems, Inc. GBX 2026-07-29 00884450022689 One-Step™ Merit Medical Systems, Inc. GBX 2026-07-29 00884450022764 One-Step™ Merit Medical Systems, Inc. GBX 2026-07-29 00884450024010 One-Step™ Merit Medical Systems, Inc. GBX 2026-07-29 00884450024027 One-Step™ Merit Medical Systems, Inc. GBX 2026-07-29 00840456202692 JMU JMU DENTAL, INC GBX 2026-07-27 00840456202708 JMU JMU DENTAL, INC GBX 2026-07-27 00884450014523 ReSolve®, StayFIX®, Merit Medical Systems, Inc. GBX 2026-07-16 00840456216750 JMU JMU DENTAL, INC GBX 2026-06-22 00840456216767 JMU JMU DENTAL, INC GBX 2026-06-22 00840456216774 JMU JMU DENTAL, INC GBX 2026-06-22 17350128050006 LinkUS Drain Interlinked AB GBX 2026-05-31 10080196995998 MEDLINE MEDLINE INDUSTRIES, INC. GBX 2024-12-12 10080196128839 Medline MEDLINE INDUSTRIES, INC. GBX 2023-12-27 10080196997633 Medline MEDLINE INDUSTRIES, INC. GBX 2023-12-27 08034139292823 Thoracic Catheter, Straight Fr 18 REDAX SPA GBX 2021-05-07 08034139292830 Thoracic Catheter, Straight Fr 21 REDAX SPA GBX 2021-05-07 08034139292847 Thoracic Catheter, Straight Fr 24 REDAX SPA GBX 2021-05-07 08034139292861 Thoracic Catheter, Straight Fr 30 REDAX SPA GBX 2021-05-07