VersaCross Access Solution

Basic Information

• Brand Name: VersaCross Access Solution
• Primary DI: 00685447011552
• Version / Model: VXSK0004
• Catalog Number: NA
• Company Name: Baylis Médicale Cie Inc
• Labeler DUNS: 249225954
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-08
• Public Version: 5
• Public Version Date: 2023-12-08
• Public Version Status: Update
• Public Device Record Key: 30ee14bf-7cf2-4ebb-8994-7fb5b4db9391

Device Description

1 x VersaCross Transseptal Sheath (including 1 x J-tip Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXF	Catheter, Septostomy	Cardiovascular	870.5175	2
DYB	Introducer, Catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00685447011552	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			8.5F 63cm 55° Curve VersaCross Transseptal Sheath with Large Curve D1 Dilator (180cm J-tip Guidewire with OD=0.035in); 180cm J-tip VersaCross RF Wire with OD=0.035in (10ft (3m) Connector Cable)