STRAIGHT ILLUM LASER PROBE,23G IRIDEX/B&L & 19G NEEDLE

Basic Information

• Brand Name: STRAIGHT ILLUM LASER PROBE,23G IRIDEX/B&L & 19G NEEDLE
• Primary DI: 13700773720641
• Version / Model: S9.1401.23
• Company Name: FCI S A S FCI 20 22
• Labeler DUNS: 763408366
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-29
• Public Version: 1
• Public Version Date: 2021-06-07
• Public Version Status: New
• Public Device Record Key: 55e622c2-beda-4969-9152-5fc8156d25b1

Device Description

STRAIGHT ILLUM LASER PROBE,23G IRIDEX/B&L & 19G NEEDLE

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HQB	Photocoagulator And Accessories	Ophthalmic	886.4690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61162	Ophthalmic laser system beam guide	A sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	23700773720648	GS1		10	In Commercial Distribution
Primary	13700773720641	GS1