HEART XS

Basic Information

• Brand Name: HEART XS
• Primary DI: 04046963756444
• Version / Model: FC121R
• Catalog Number: FC121R
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-24
• Public Version: 2
• Public Version Date: 2021-05-10
• Public Version Status: Update
• Public Device Record Key: 60ecfab4-938c-451b-8709-1b4b000095d7

Device Description

HEART XS Valve Hook, (250 mm), malleable, (65 mm), depth: 18 mm, 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
GDG	HOOK, SURGICAL, GENERAL & PLASTIC SURGERY	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46774	Surgical retractor/retraction system blade, reusable	A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046963756444	GS1

Customer Contacts

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