VALVE XS

Basic Information

• Brand Name: VALVE XS
• Primary DI: 04046963756987
• Version / Model: FC360R
• Catalog Number: FC360R
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-24
• Public Version: 2
• Public Version Date: 2022-02-25
• Public Version Status: Update
• Public Device Record Key: 2bd3f41c-2a2d-4d2a-86e8-1ac57727f01e
• Distribution End Date: 2021-08-02

Device Description

VALVE XS Atrium Retractor, complete set, consisting of FC361R, FC362R, FC363R, FC364R, FC365R, FC366R, FC367R, non-sterile, reusable

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
GAD	RETRACTOR	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15896	General-purpose casework	Furniture consisting of different units, e.g., cabinets, shelves, racks, worktops, combined and installed in a healthcare facility to provide users with a general-purpose functional work and storage place. This will also separate the floor/room area creating a practical discrete working environment for the staff. The units are used to store materials, supplies, devices, records, samples, and other items. This furniture is usually modular and constructed using thicker panels and more long-lasting surface finishes than ordinary office/domestic furniture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046963756987	GS1

Customer Contacts

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