Home GUDID 10827002189697 Advance
Primary DI 10827002189697
Brand Advance
Company COOK INCORPORATED
Model G18969
Catalog number PTAX4-14-110-4-4
Device description Advance, 14LP Low Profile PTA Balloon Dilatation Catheter
Published 2016-09-24
Public version status Update
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
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10827002189697 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10827002189697 10827002189697
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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in dark, dry, cool place.
Regulatory Flags# DUNS number 042823948 Device count 1 Lot or batch true Manufacturing date on label true Expiration 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 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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