Chord-X Premeasured Loops and Suture System

FDA UDI

Class II (US FDA UDI)

by On-X Life Technologies, Inc.

Identity

Trade Name: Chord-X Premeasured Loops and Suture System FDA UDI
Generic Name: Polyolefin/fluoropolymer suture, monofilament FDA UDI
Device Name: Artificial chordal replacement prosthesis FDA UDI
Model / Reference: CXL-20-2212-16 FDA UDI
Description: Artificial chordal replacement prosthesis FDA UDI

Identifiers

Catalog Number: CXL-20-2212-16 FDA UDI
Primary DI / UDI-DI: 00813570020022 FDA UDI
510(k) Number: K141060 FDA UDI
FDA Product Code: PAW FDA UDI
GMDN Term: Polyolefin/fluoropolymer suture, monofilament FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3470 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — .3195 Millimeter FDA UDI

Category: Polyolefin/fluoropolymer suture, monofilament

Chord-X Premeasured Loops and Suture System by On-X Life Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyolefin/fluoropolymer suture, monofilament.

SUTUMED — Unilene Sac · Class II
DemeLENE — DemeTECH Corp · Class II
DemeLENE — DemeTECH Corp · Class II
ATRAMAT — Internacional Farmacéutica S.A DE C.V · Class II
DemeLENE — DemeTECH Corp · Class II
WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
Premilene — B BRAUN SURGICAL SA · Class II
DEKNATEL — TELEFLEX INCORPORATED · Class II

Cleared under the same submission

K141060 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: On-X Life Technologies, Inc.

Sources (1)

FDA UDI ada46b69-d869-4f48-b4bd-63dbab754afa 37 fields · synced May 30, 2026