SOLOPATH

Basic Information

• Brand Name: SOLOPATH
• Primary DI: 00389701012148
• Version / Model: STFI-1435
• Catalog Number: STFI-1435
• Company Name: TERUMO MEDICAL CORPORATION
• Labeler DUNS: 131489882
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-17
• Public Version: 3
• Public Version Date: 2020-03-12
• Public Version Status: Update
• Public Device Record Key: 36fff2a6-26ad-4416-a6c5-35b0fb3398a1
• Distribution End Date: 2019-11-15

Device Description

SOLOPATH Balloon Expandable TransFemoral System

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
58865	Vascular catheter introduction set, nonimplantable	A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50389701012143	GS1	Carton	39	Not in Commercial Distribution	2019-11-15
Primary	00389701012148	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	35	Centimeter
Device Size Text, specify			Inner Diameter: 14 FrenchOuter Diameter: 17 French
Device Size Text, specify			Maximum Rated Inflation Pressure: 20 atm/bar or 2026 kPa or 294 psi

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid direct sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Do not store at extreme temperature and humidity