AccessGUDID - DEVICE: VersaCross Steerable Access Solution (00685447012153)

GUDID

Device Identifier (DI) Information

Brand Name: VersaCross Steerable Access Solution
Version or Model: VSTK0024
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NA
Company Name: Baylis Médicale Cie Inc

Primary DI Number: 00685447012153
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 249225954 *Terms of Use

Device Description: 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))

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:	Yes
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?
47247	Cardiac transseptal access set	A collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It includes a vascular guide-catheter (which may be referred to as a steerable introducer) with a transseptal needle to create the puncture, and typically includes additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXF	Catheter, Septostomy
DYB	Introducer, Catheter

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Device Size Text, specify: 72cm 8.5F VersaCross Steerable Sheath with Small Curl (incl. 95cm Large Curve D1 Dilator; 180cm J-Tip Guidewire OD=0.035in); 230cm Pigtail VersaCross RF Wire OD=0.035in (10ft(3m) Connector Cable)

Device Record Status

Public Device Record Key: 6e16a2f1-5ac7-4582-91dc-3818cb98fe28
Public Version Date: December 08, 2023
Public Version Number: 5
DI Record Publish Date: August 04, 2022