AccessGUDID - DEVICE: Chord-X Chordal Sizer (00851788001495)

GUDID

Device Identifier (DI) Information

Brand Name: Chord-X Chordal Sizer
Version or Model: CXCS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CXCS
Company Name: ON-X LIFE TECHNOLOGIES, INC.

Primary DI Number: 00851788001495
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 844782318 *Terms of Use

Device Description: for sizing or configuring chordal replacement prostheses during mitral valve repair

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62517	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	Instrument, Manual, Surgical, General Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dfabd769-0946-4cfe-9ea6-236ceb6f5219
Public Version Date: October 20, 2023
Public Version Number: 1
DI Record Publish Date: October 12, 2023