Chord-X Premeasured Loops and Suture System CXL-20-1812-0

GUDID 00813570020602

Artificial chordal replacement prosthesis

ON-X LIFE TECHNOLOGIES, INC.

Polyolefin suture, monofilament
Primary Device ID00813570020602
NIH Device Record Key16547729-356e-4acf-87d8-d311a54ba8fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameChord-X Premeasured Loops and Suture System
Version Model NumberCXL-20-1812-0
Catalog NumberCXL-20-1812-0
Company DUNS844782318
Company NameON-X LIFE TECHNOLOGIES, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com
Phone512-339-8000
Emailonx@onxlti.com

Device Dimensions

Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter
Outer Diameter0.3195 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100813570020206 [Primary]
GS100813570020602 [Package]
Contains: 00813570020206
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PAWNonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-25
Device Publish Date2015-12-01

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