ASCENDRA 3 INTRODUCER SHEATH SET

Basic Information

• Brand Name: ASCENDRA 3 INTRODUCER SHEATH SET
• Primary DI: 00690103191912
• Version / Model: 9120ISA
• Catalog Number: 9120ISA
• 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: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c2eb279c-a0bd-499a-9f6f-e4b70d484334

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: 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
NPT	Aortic valve, prosthesis, percutaneously delivered	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
10678	Catheter introducer	A sterile tubular plastic sheath designed to be percutaneously placed into a natural body space (e.g., vein, artery, ventricle, peritoneal cavity), or an artificial passageway (e.g., created by means of a catheter tunneller), and through which a catheter is subsequently inserted (by pushing) for placement. It typically has a handle (e.g., T-shaped wing grips) at the proximal end, and may have radiopaque graduated markings at the working end to make it visible on x-ray. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103191912	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			NOMINAL BALLOON DIAMETER