Home GUDID B090C351351 XO Cross 35
Primary DI B090C351351
Brand XO Cross 35
Company ZIEN MEDICAL TECHNOLOGIES, INC.
Model C35-135
Catalog number C35-135
Device description The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Published 2022-06-20
Public version status New
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 B090C351351 Package HIBCC 1 In Commercial Distribution B090C351352 Package HIBCC 10 In Commercial Distribution B090C351350 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Vascular guide-catheter, single-use A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 3.9 French Catheter Working Length 135 Centimeter Crossing Profile 3.2 French Introducer Sheath Compatibilit 4 French
Regulatory Flags# DUNS number 017535668 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false 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# 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