Durette® II, SS External Ocular Laser Shields, regular (non glare)

Basic Information

• Brand Name: Durette® II, SS External Ocular Laser Shields, regular (non glare)
• Primary DI: 20697660002297
• Version / Model: 21-335
• Company Name: Oculo-Plastik Inc
• Labeler DUNS: 257382580
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-07
• Public Version: 1
• Public Version Date: 2019-11-15
• Public Version Status: New
• Public Device Record Key: 343bbde9-49a6-4fe2-8d8c-8665f928ddc6

Device Description

Durette® II External laser shields are designed to protect patient's eyes during laser treatment. They are installed on the face over the eyelids. It is provided with a fastening system that fits as many people as possible. The regular size is used in most treatments on the face, while the small size is used when the surgeon wants to go closer to the eyes. The entire surface of the device is non-glare treated to diffuse the laser. The medical staff uses the instrument during surgery. It must be cleaned and sterilized before use.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
IWS	Shield, Eye, Radiological	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64273	Epiocular radiation shield, reusable	An opaque ocular covering intended to be used to shield the entire eye area of a patient or healthcare personnel from exposure to primary and scattered radiation (ionizing and/or non-ionizing) during a medical procedure [e.g., CT scan, dermatological laser treatment, phototherapy]. It is made of materials that prevent the transmission of harmful radiation to the eyes (e.g., lead, tungsten, plastic), and is typically in the form of a single or double opaque shield adhered to the face in front of the eyes (i.e. not directly on the corneal surface); it is not designed as goggles or spectacles. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20697660002297	GS1

Customer Contacts

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