Home GUDID 04540778153752 METACROSS RX
Primary DI 04540778153752
Brand METACROSS RX
Company KANEKA CORPORATION
Model BD-L80080ER
Catalog number BD-L80080ER
Device description METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
Published 2016-08-26
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 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 04540778153752 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04540778153752 04540778153752 4540778153752
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 microsurgical blades (atherotomes) to score the plaque. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a cool, dry, dark place. Avoid exposure to water, direct sunlight.
Regulatory Flags# DUNS number 690535406 Device count 1 Lot or batch true Serial number 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 07613327623338 AXS Lift Stryker Corporation DQY 2025-03-04 07613327623376 AXS Lift Stryker Corporation DQY 2025-03-04 07613327417203 AXS Catalyst 7 Stryker Corporation DQY 2019-05-13 07613327417227 AXS Catalyst 7 Stryker Corporation DQY 2019-05-13 07613327313888 DAC 038 Stryker Corporation DQY 2016-09-21 07613327313901 DAC 057 Stryker Corporation DQY 2016-09-21 07613327313932 DAC 070 Stryker Corporation DQY 2016-09-21 07613327313949 DAC 057 Stryker Corporation DQY 2016-09-21 08033477054322 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054360 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054384 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054391 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054407 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054421 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054438 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477048772 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048802 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048833 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048864 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048888 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048925 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048956 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048987 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049014 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049045 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049069 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049076 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049106 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049137 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049168 REEF HP MEDTRONIC, INC. DQY 2016-06-19
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