TorFlex Transseptal Dilator

Basic Information

• Brand Name: TorFlex Transseptal Dilator
• Primary DI: 00685447001119
• Version / Model: TFD8-38-67S0
• Company Name: Baylis Médicale Cie Inc
• Labeler DUNS: 249225954
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 6
• Public Version Date: 2023-12-08
• Public Version Status: Update
• Public Device Record Key: 5a7b6e31-255a-4a26-90c4-51dc70a031ef
• Distribution End Date: 2017-03-20

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
DYB	Introducer, Catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47492	Cardiac transseptal access dilator	A device designed to be used with a transseptal vascular guide-catheter (not included) to penetrate the interatrial septum to gain left-heart access during a transseptal catheterization procedure. It is typically a long, thin tube made of plastic that is curved and round-nosed at the distal end for positioning against the atrial septum, and to accommodate in its lumen a Brockenbrough type curved puncture needle (not included). It will typically have a marker (e.g., a hub) to identify the proximal portion of the dilator and to aid placement of the guide-catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00685447001119	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	8	French
Length	67	Centimeter
Device Size Text, specify			Curve 0; Body OD = 0.105 inch; Tip ID = 0.038 inch