NOIR

Basic Information

• Brand Name: NOIR
• Primary DI: 04046964725845
• Version / Model: FT533B
• Catalog Number: FT533B
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-06
• Public Version: 1
• Public Version Date: 2022-05-16
• Public Version Status: New
• Public Device Record Key: 621b1b19-e319-49cd-8111-29162d9db97e

Device Description

YASARGIL NOIR Clip Applier Forceps, 15 °, angled upwards, 8 3/4", (220 mm), working length: 3 1/2", (90 mm), bayonet-shaped, narrowpattern, with ratchet, stainless steel, black, 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: No
• 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
HCI	APPLIER, ANEURYSM CLIP	Neurology	882.4175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32591	Aneurysm clip applier	A surgical instrument designed for the application/insertion of aneurysm clips (devices for approximating the edges of the neck of an aneurysm or for the prevention of bleeding from small individual blood vessels). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046964725845	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K211572	000