Tornus ES

Basic Information

• Brand Name: Tornus ES
• Primary DI: 04547327156493
• Version / Model: TES0025S
• Company Name: ASAHI INTECC CO., LTD.
• Labeler DUNS: 690711189
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-28
• Public Version: 1
• Public Version Date: 2025-02-05
• Public Version Status: New
• Public Device Record Key: be7d911e-97fd-4ea6-bb91-68b0f88a5896

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
FGE	Stents, drains and dilators for the biliary ducts	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38821	Endoscopic-access dilator, single-use	A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04547327156493	GS1

Device Sizes

Type	Value	Unit	Text
Length	195	Centimeter
Catheter Gauge	7	French