FDA.reportPublic FDA data

Chord-X Premeasured Loops and Suture System

Primary DI
00813570020015
Brand
Chord-X Premeasured Loops and Suture System
Company
ON-X LIFE TECHNOLOGIES, INC.
Model
CXL-20-2212-12
Catalog number
CXL-20-2212-12
Device description
Artificial chordal replacement prosthesis
Published
2015-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PAWNonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAWNonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or ReplacementCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141060000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141060000CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENTOn-X Life Technologies, Inc.2014-06-06PAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813570020411PackageGS15In Commercial Distribution
00813570020015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813570020411008135700204118135700204110813570020411
00813570020015008135700200158135700200150813570020015

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.3195Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
512-339-8000onx@onxlti.com

Regulatory Flags#

DUNS number
844782318
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851788001495Chord-X Chordal SizerCXCSCXCS2023-10-12
00851788001020On-X Heart Valve InstrumentsONXI2-19RONXI2-19R2023-08-09
00851788001037On-X Heart Valve InstrumentsONXI2-21RONXI2-21R2023-08-09
00851788001044On-X Heart Valve InstrumentsONXI2-23RONXI2-23R2023-08-09
00851788001051On-X Heart Valve InstrumentsONXI2-25RONXI2-25R2023-08-09
00851788001068On-X Heart Valve InstrumentsONXI3-19SONXI3-19S2023-08-09
00851788001082On-X Heart Valve InstrumentsONXI2-19SONXI2-19S2023-08-09
00851788001099On-X Heart Valve InstrumentsONXI2-21SONXI2-21S2023-08-09
00851788001105On-X Heart Valve InstrumentsONXI2-23SONXI2-23S2023-08-09
00851788001112On-X Heart Valve InstrumentsONXI2-25SONXI2-25S2023-08-09
00851788001129On-X Heart Valve InstrumentsONXI2-27-33SONXI2-27-33S2023-08-09
00851788001136On-X Heart Valve InstrumentsONXI2-23-25SONXI2-23-25S2023-08-09
00851788001143On-X Heart Valve InstrumentsONXI2-27-29SONXI2-27-29S2023-08-09
00851788001150On-X Heart Valve InstrumentsONXI2-HONXI2-H2023-08-09
00851788001167On-X Heart Valve InstrumentsONXI2-LPONXI2-LP2023-08-09
00851788001174On-X Heart Valve InstrumentsONXI2-CTONXI2-CT2023-08-09
00851788001181On-X Heart Valve InstrumentsONXI3-21SONXI3-21S2023-08-09
00851788001198On-X Heart Valve InstrumentsONXI3-23SONXI3-23S2023-08-09
00851788001556On-X Heart Valve InstrumentsONXI3-27-29SONXI3-27-29S2023-08-09
00851788001563On-X Heart Valve InstrumentsONXI3-23-25SONXI3-23-25S2023-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813570020008Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020022Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020039Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020046Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020053Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020060Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020077Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020084Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020091Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020107Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020114Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020121Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020138Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020145Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020152Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020169Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020176Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020183Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020190Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020206Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020213Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020220Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020237Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020244Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020251Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020268Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020275Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020282Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020299Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01
00813570020305Chord-X Premeasured Loops and Suture SystemON-X LIFE TECHNOLOGIES, INC.PAW2015-12-01