XO Cross 14 - The XO Cross device is a support catheter - ZIEN MEDICAL TECHNOLOGIES, INC.

Duns Number:017535668

Device Description: The XO Cross device is a support catheter intended to guide and support a guidewire during 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.

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More Product Details

Catalog Number

C14-175

Brand Name

XO Cross 14

Version/Model Number

C14-175

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Device Record Status

Public Device Record Key

54131682-10ca-457e-aec9-8bdf7dfcb2dc

Public Version Date

June 28, 2022

Public Version Number

1

DI Record Publish Date

June 20, 2022

Additional Identifiers

Package DI Number

B090C141751

Quantity per Package

1

Contains DI Package

B090C141750

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Carton

"ZIEN MEDICAL TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 24