XO Cross 35

Primary DI
B090C351350
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
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B090C351351PackageHIBCC1Not in Commercial Distribution
B090C351352PackageHIBCC10Not in Commercial Distribution
B090C351350PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA 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
TypeValueUnit
Catheter Gauge3.9French
Catheter Working Length135Centimeter
Crossing Profile3.2French
Introducer Sheath Compatibilit4French

Regulatory Flags#

DUNS number
017535668
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850068519279SAM MedicalIO805IO8052026-05-07
00850068519309SAM MedicalIO806IO8062026-05-07
00850068519330SAM MedicalIO807IO8072026-05-07
B090MT630MorTan MT632026-02-17
B090MT2020MorTanMT202 2026-02-10
B090MT2021MorTanMT202 2026-02-10
B090XC2201450XO ConstrainXC2.20-1452026-02-03
B090XC2201451XO ConstrainXC2.20-1452026-02-03
00850068519231SAM Medical IO8422025-12-09
00850068519248SAM Medical IO847W-1P2025-12-09
00850068519255SAM Medical IO846W-1P2025-12-09
00850068519262SAM Medical IO845W-1P2025-12-09
10850068519238SAM Medical IO8422025-12-09
10850068519245SAM Medical IO847W-1P2025-12-09
10850068519252SAM Medical IO846W-1P2025-12-09
10850068519269SAM Medical IO845W-1P2025-12-09
B090P110900VentiV ScientificP11-090P11-0902025-11-24
B090P11090F0VentiV ScientificP11-090-FP11-090-F2025-11-24
B090P110901VentiV ScientificP11-090P11-0902025-11-24
B090P11090F1VentiV ScientificP11-090-FP11-090-F2025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
07613327417203AXS Catalyst 7Stryker CorporationDQY2019-05-13
07613327417227AXS Catalyst 7Stryker CorporationDQY2019-05-13
07613327313888DAC 038Stryker CorporationDQY2016-09-21
07613327313901DAC 057Stryker CorporationDQY2016-09-21
07613327313932DAC 070Stryker CorporationDQY2016-09-21
07613327313949DAC 057Stryker CorporationDQY2016-09-21
08033477054322Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054360Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054384Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054391Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054407Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054421Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054438Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477048772REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048802REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048833REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048864REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048888REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048925REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048956REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048987REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049014REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049045REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049069REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049076REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049106REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049137REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049168REEF HPMEDTRONIC, INC.DQY2016-06-19