OptiSet™

Basic Information

• Brand Name: OptiSet™
• Primary DI: 07290117770955
• Version / Model: OptiSet™
• Company Name: LUMENIS BE LTD
• Labeler DUNS: 600763501
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-19
• Public Version: 2
• Public Version Date: 2023-03-02
• Public Version Status: Update
• Public Device Record Key: 08fbeec4-ce3f-4b26-bde6-7c79a42da2f3

Device Description

17290117770952 - OptiSet™ Master 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: Yes
• 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
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	886.4750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64272	Radiation/mechanical corneal shield, single-use	A protective device intended to be placed on the cornea of a patient to protect the eyes from physical damage and/or exposure to primary and scattered radiation during a medical procedure [e.g., periorbital surgery, x-ray/CT scan, dermatological laser treatment]. It is typically in the form of a dome and is made of non-biodegradable, durable materials (e.g., lead, tungsten, glass, plastic) that provide mechanical protection and/or prevent the transmission of harmful radiation to the eyes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290117770955	GS1
Package	17290117770952	GS1		24	In Commercial Distribution