Primary Device ID | B090C141751 |
NIH Device Record Key | 54131682-10ca-457e-aec9-8bdf7dfcb2dc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | XO Cross 14 |
Version Model Number | C14-175 |
Catalog Number | C14-175 |
Company DUNS | 017535668 |
Company Name | ZIEN MEDICAL TECHNOLOGIES, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Catheter Gauge | 2 French |
Introducer Sheath Compatibilit | 2.9 French |
Catheter Working Length | 175 Centimeter |
Crossing Profile | 1.6 French |
Catheter Gauge | 2 French |
Introducer Sheath Compatibilit | 2.9 French |
Catheter Working Length | 175 Centimeter |
Crossing Profile | 1.6 French |
Catheter Gauge | 2 French |
Introducer Sheath Compatibilit | 2.9 French |
Catheter Working Length | 175 Centimeter |
Crossing Profile | 1.6 French |
Catheter Gauge | 2 French |
Introducer Sheath Compatibilit | 2.9 French |
Catheter Working Length | 175 Centimeter |
Crossing Profile | 1.6 French |
Catheter Gauge | 2 French |
Introducer Sheath Compatibilit | 2.9 French |
Catheter Working Length | 175 Centimeter |
Crossing Profile | 1.6 French |
Catheter Gauge | 2 French |
Introducer Sheath Compatibilit | 2.9 French |
Catheter Working Length | 175 Centimeter |
Crossing Profile | 1.6 French |
Catheter Gauge | 2 French |
Introducer Sheath Compatibilit | 2.9 French |
Catheter Working Length | 175 Centimeter |
Crossing Profile | 1.6 French |
Catheter Gauge | 2 French |
Introducer Sheath Compatibilit | 2.9 French |
Catheter Working Length | 175 Centimeter |
Crossing Profile | 1.6 French |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B090C141750 [Primary] |
HIBCC | B090C141751 [Package] Contains: B090C141750 Package: Shelf Carton [1 Units] In Commercial Distribution |
HIBCC | B090C141752 [Package] Package: Shipper [10 Units] In Commercial Distribution |
DQY | Catheter, Percutaneous |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-06-28 |
Device Publish Date | 2022-06-20 |
B090C141751 | The XO Cross device is a support catheter intended to guide and support a guidewire during acces |
B090C14135H1 | The XO Cross device is a support catheter intended to guide and support a guidewire during acces |
B090C141351 | The XO Cross device is a support catheter intended to guide and support a guidewire during acces |
B090C140901 | The XO Cross device is a support catheter intended to guide and support a guidewire during acces |
B090C14175H1 | The XO Cross device is a support catheter intended to guide and support a guidewire during acces |
B090C14090H1 | The XO Cross device is a support catheter intended to guide and support a guidewire during acces |