VersaCross RF Wire

Basic Information

• Brand Name: VersaCross RF Wire
• Primary DI: 00685447011101
• Version / Model: VXW-35-230-J-WM
• Company Name: Baylis Médicale Cie Inc
• Labeler DUNS: 249225954
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-19
• Public Version: 3
• Public Version Date: 2023-12-08
• Public Version Status: Update
• Public Device Record Key: 1c3704a7-a501-4e5d-b184-f527707b0ec8

Device Description

1 x VersaCross RF Wire; 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

GMDN Terms

Code	Name	Definition	Implantable	Status
61875	Endoscopic electrosurgical electrode, monopolar, single-use	A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00685447011101	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			230 cm VersaCross RF Wire with Wire Diameter = 0.035 in and Curve Radius = 4.5 mm J-Tip; 10 ft Connector Cable (Single Use)