Home GUDID H373BCL264536 GORE Tri-Lobe Balloon Catheter
Primary DI H373BCL264536
Brand GORE Tri-Lobe Balloon Catheter
Company W. L. Gore & Associates, Inc.
Model BCL2645
Catalog number BCL2645
Device description TRI-LOBE BALLOON LARGE CATH
Published 2017-02-13
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 DQY CATHETER, PERCUTANEOUS
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQY Catheter, Percutaneous Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00733132605224 Primary GS1 0 H373BCL264536 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00733132605224 00733132605224 733132605224 0733132605224
GMDN Terms# Term, Definition table Term Definition Peripheral angioplasty balloon catheter, basic A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 18 French Length 104 Centimeter Length 108 Centimeter
Regulatory Flags# DUNS number 967358115 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00733132606290 GORE PROPATEN Vascular Graft Pediatric Shunt HPT040015A HPT040015A 2017-02-13 00733132606313 GORE PROPATEN Vascular Graft Pediatric Shunt HPT050005A HPT050005A 2017-02-13 00733132606351 GORE PROPATEN Vascular Graft Pediatric Shunt HPT050015A HPT050015A 2017-02-13 00733132606375 GORE PROPATEN Vascular Graft Pediatric Shunt HPT060015A HPT060015A 2017-02-13 00733132606399 GORE PROPATEN Vascular Graft Pediatric Shunt HPT350005A HPT350005A 2017-02-13 00733132606436 GORE PROPATEN Vascular Graft Pediatric Shunt HPT350015A HPT350015A 2017-02-13 00733132607068 GORE PROPATEN Vascular Graft IRH060545A IRH060545A 2017-02-13 00733132607129 GORE PROPATEN Vascular Graft IRH463845A IRH463845A 2017-02-13 00733132607143 GORE PROPATEN Vascular Graft IRH473845A IRH473845A 2017-02-13 00733132653690 GORE SYNECOR Preperitoneal Biomaterial GKWR4040 GKWR4040 2022-11-08 00733132653706 GORE SYNECOR Preperitoneal Biomaterial GKWR3030 GKWR3030 2022-11-08 00733132653713 GORE SYNECOR Preperitoneal Biomaterial GKWR4050 GKWR4050 2022-11-08 00733132653720 GORE SYNECOR Preperitoneal Biomaterial GKWR3535 GKWR3535 2022-11-08 00733132653737 GORE SYNECOR Preperitoneal Biomaterial GKWR3040 GKWR3040 2022-11-08 00733132653744 GORE SYNECOR Preperitoneal Biomaterial GKWC09 GKWC09 2021-10-05 00733132605798 GORE PROPATEN Vascular Graft H060010A H060010A 2017-02-13 00733132605811 GORE PROPATEN Vascular Graft H060040A H060040A 2017-02-13 00733132605835 GORE PROPATEN Vascular Graft H060060A H060060A 2017-02-13 00733132605859 GORE PROPATEN Vascular Graft H060080A H060080A 2017-02-13 00733132605873 GORE PROPATEN Vascular Graft H080040A H080040A 2017-02-13
Other Devices Sharing Product Codes# 
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