Home GUDID 00851616007309 Paladin
Primary DI 00851616007309
Brand Paladin
Company Contego Medical, Inc.
Model 5x20
Catalog number PD-5020-140-2
Device description The Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP), is indicated for PercutaneousTransluminal Angioplasty (PTA) in the carotid arteries with capture and removal of embolic material
Published 2023-09-05
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name LIT Catheter, Angioplasty, Peripheral, Transluminal NTE Temporary Carotid Catheter For Embolic Capture
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular 2 NTE Temporary Carotid Catheter For Embolic Capture Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00851616007309 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 00851616007309 00851616007309 851616007309 0851616007309
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.
Regulatory Flags# DUNS number 048268128 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08033477048772 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048802 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048833 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048864 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048888 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048925 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048956 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048987 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049014 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049045 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049069 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049076 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049106 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049137 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049168 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049199 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049212 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049229 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049250 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049281 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049311 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049373 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049434 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049397 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049090 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048727 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048734 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048765 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048796 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048819 REEF HP MEDTRONIC, INC. LIT 2016-06-19
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