Home GUDID 00851788001495 Chord-X Chordal Sizer
Primary DI 00851788001495
Brand Chord-X Chordal Sizer
Company ON-X LIFE TECHNOLOGIES, INC.
Model CXCS
Catalog number CXCS
Device description for sizing or configuring chordal replacement prostheses during mitral valve repair
Published 2023-10-12
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name MDM Instrument, Manual, Surgical, General Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00851788001495 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00851788001495 00851788001495 851788001495 0851788001495
GMDN Terms# Term, Definition table Term Definition Chordae tendinae sizer A sterile, hand-held manual surgical instrument intended to be used during mitral valve repair to determine the proper length of a chordal replacement prosthesis used to repair the chordae tendinae. It is a slender tool with a gauge and extendable distal hooks designed to measure the distance between the edge of the valve leaflet and the planned site of attachment of the chordal replacement to the papillary muscle. This is a single-use device.
Regulatory Flags# DUNS number 844782318 Device count 1 Premarket 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 DI Brand Model Catalog Published 00851788001020 On-X Heart Valve Instruments ONXI2-19R ONXI2-19R 2023-08-09 00851788001037 On-X Heart Valve Instruments ONXI2-21R ONXI2-21R 2023-08-09 00851788001044 On-X Heart Valve Instruments ONXI2-23R ONXI2-23R 2023-08-09 00851788001051 On-X Heart Valve Instruments ONXI2-25R ONXI2-25R 2023-08-09 00851788001068 On-X Heart Valve Instruments ONXI3-19S ONXI3-19S 2023-08-09 00851788001082 On-X Heart Valve Instruments ONXI2-19S ONXI2-19S 2023-08-09 00851788001099 On-X Heart Valve Instruments ONXI2-21S ONXI2-21S 2023-08-09 00851788001105 On-X Heart Valve Instruments ONXI2-23S ONXI2-23S 2023-08-09 00851788001112 On-X Heart Valve Instruments ONXI2-25S ONXI2-25S 2023-08-09 00851788001129 On-X Heart Valve Instruments ONXI2-27-33S ONXI2-27-33S 2023-08-09 00851788001136 On-X Heart Valve Instruments ONXI2-23-25S ONXI2-23-25S 2023-08-09 00851788001143 On-X Heart Valve Instruments ONXI2-27-29S ONXI2-27-29S 2023-08-09 00851788001150 On-X Heart Valve Instruments ONXI2-H ONXI2-H 2023-08-09 00851788001167 On-X Heart Valve Instruments ONXI2-LP ONXI2-LP 2023-08-09 00851788001174 On-X Heart Valve Instruments ONXI2-CT ONXI2-CT 2023-08-09 00851788001181 On-X Heart Valve Instruments ONXI3-21S ONXI3-21S 2023-08-09 00851788001198 On-X Heart Valve Instruments ONXI3-23S ONXI3-23S 2023-08-09 00851788001556 On-X Heart Valve Instruments ONXI3-27-29S ONXI3-27-29S 2023-08-09 00851788001563 On-X Heart Valve Instruments ONXI3-23-25S ONXI3-23-25S 2023-08-09 00851788001570 On-X Heart Valve Instruments ONXI3-27-33S ONXI3-27-33S 2023-08-09
Other Devices Sharing Product Codes# 
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