VALVE XS

Basic Information

• Brand Name: VALVE XS
• Primary DI: 04046963954949
• Version / Model: FC359R
• Catalog Number: FC359R
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-17
• Public Version: 2
• Public Version Date: 2021-09-29
• Public Version Status: Update
• Public Device Record Key: aa8d54c3-bc45-473d-838c-f2ae68f4b246

Device Description

VALVE XS VALVE PUSHER 370MMM

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62685	Heart valve prosthesis repositioning tool	A hand-held manual surgical instrument intended to be used to realign or reposition a heart valve prosthesis after initial insertion and positioning with a heart valve prosthesis holder. The device may be a one-piece instrument or attached to a separate handle, and is available in a range of configurations for the aortic, mitral, or tricuspid heart valve. It is typically made of plastic materials. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046963954949	GS1

Customer Contacts

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