Catalog Number

-

Brand Name

X-pedionTM

Version/Model Number

103-0605-200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K124007

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

39c051af-2986-4389-9f2a-bfa2f43574f0

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

July 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-