FS DISPOSABLE INTERFACE

Basic Information

• Brand Name: FS DISPOSABLE INTERFACE
• Primary DI: 15050474534688
• Version / Model: 590106AN
• Catalog Number: 590106AN
• Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Labeler DUNS: 103021940
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-02
• Public Version: 4
• Public Version Date: 2020-02-26
• Public Version Status: Update
• Public Device Record Key: 555d9105-726e-4b32-a312-8b7f7beef6c4

Device Description

20 PROCEDURE PACK

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
GEX	Powered laser surgical instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41707	Laser beam delivery unit holder	A device designed to be used together with a laser delivery unit to provide support to the delivery unit during the operation of the laser. The holder will help with the positioning of the final laser beam output and increase safety from inadvertent movement which would be undesirable. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15050474534688	GS1

Customer Contacts

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