AccessGUDID - DEVICE: XO Cross 35 (B090C35175H0)

GUDID

Device Identifier (DI) Information

Brand Name: XO Cross 35
Version or Model: C35-175-H
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C35-175-H
Company Name: ZIEN MEDICAL TECHNOLOGIES, INC.

Primary DI Number: B090C35175H0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017535668 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17846	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQY	Catheter, Percutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 3.9 French
Crossing Profile: 3.2 French
Catheter Working Length: 175 Centimeter
Introducer Sheath Compatibility: 4 French

Device Record Status

Public Device Record Key: c82828f4-8ec3-47e2-9f76-374470017d47
Public Version Date: November 01, 2022
Public Version Number: 1
DI Record Publish Date: October 24, 2022