18F X 36CM EDWARDS EXPANDABLE INTRODUCER SHEATH SET

Basic Information

• Brand Name: 18F X 36CM EDWARDS EXPANDABLE INTRODUCER SHEATH SET
• Primary DI: 00690103192117
• Version / Model: 918ES26
• Catalog Number: 918ES26A
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-08-30
• Public Version: 4
• Public Version Date: 2019-06-07
• Public Version Status: Update
• Public Device Record Key: 4eb913b7-ba82-4097-b130-bd6f0d59eccc

Device Description

EDWARDS EXPANDABLE INTRODUCER SHEATH SET

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
NPT	Aortic valve, prosthesis, percutaneously delivered	Unknown		3

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
Primary	00690103192117	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P130009	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			18 FRENCH NOMINAL INTRODUCER SHEATH INNER DIAMETER IS COMPATIBLE WITH THE 26 MM VALVE AND DELIVERY SYSTEM