AMADEUS

Basic Information

• Brand Name: AMADEUS
• Primary DI: 07640167751198
• Version / Model: Tubing
• Catalog Number: 130.700.020
• Company Name: SIS AG, Surgical Instrument Systems
• Labeler DUNS: 480508261
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 3
• Public Version Date: 2019-11-08
• Public Version Status: Update
• Public Device Record Key: b8ae8665-aef5-42c7-9d78-b31d8fa88263

Device Description

Sterile vacuum tube for AMADEUS

Device Characteristics

• Single Use: Yes
• 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: 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
HNO	Keratome, Ac-Powered	Ophthalmic	886.4370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45150	Ophthalmic surgical procedure kit, non-medicated, single-use	A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640167751198	GS1
Unit of Use	07640167751204	GS1

Customer Contacts

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