Sophysa

Basic Information

• Brand Name: Sophysa
• Primary DI: 03760124131444
• Version / Model: TUG-45
• Company Name: SOPHYSA
• Labeler DUNS: 262951353
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2023-06-02
• Public Version: 2
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: 3dffa0d6-a77a-42e5-a994-31c4d3ee32c7

Device Description

DISPOSABLE TUBUAR SHEATH FOR CATHETER PASSER 45 CM

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
GYK	Instrument, Shunt System Implantation	Neurology	882.4545	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46801	Subcutaneous tunneller, single-use	A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760124131444	GS1
Unit of Use	13760124131441	GS1