Catalog Number

CXL-20-1838-16

Brand Name

Chord-X Premeasured Loops and Suture System

Version/Model Number

CXL-20-1838-16

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

K141060,K141060

Product Code

PAW

Product Code Name

Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

Public Device Record Key

2fcd1743-5cfb-4334-9224-9da55bc4a6bf

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

December 01, 2015

Package DI Number

00813570020671

Quantity per Package

5

Contains DI Package

00813570020275

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-