LEYLA

Basic Information

• Brand Name: LEYLA
• Primary DI: 04038653126873
• Version / Model: FF180R
• Catalog Number: FF180R
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-07
• Public Version: 4
• Public Version Date: 2023-08-25
• Public Version Status: Update
• Public Device Record Key: fddfc1d0-781c-44fe-ba8c-8c2198804931

Device Description

YASARGIL LEYLA Retractor, tray for patties, 4 3/4", (120 mm), depth: 10 mm, width: 80 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
FSM	TRAY, SURGICAL, INSTRUMENT	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42893	General-purpose bowl, reusable	A portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04038653126873	GS1

Customer Contacts

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