Cox® II, SS Ocular Laser Shield, medium (non glare), refurb.

Primary DI
10697660001767
Brand
Cox® II, SS Ocular Laser Shield, medium (non glare), refurb.
Company
Oculo-Plastik Inc
Model
21-264RE
Device description
Cox® II ocular laser shields are intended to protect the eyes during IPL and laser procedures close to the eyes and on the face. They are inserted under the eyelids, on the ocular globes for the length of the procedure. They should not be left in place more than 60 minutes. The posterior polished surface and well-polished edges are intended to avoid corneal abrasions. The anterior surface is non-reflective treated to avoid reflection of the laser beam or IPL light source. USE ONLY WITH PURE LASERS OR PURE IPL SYSTEMS. DO NOT USE WITH SYSTEMS THAT ARE INTEGRATED WITH ELECTRIC CURRENT OR RADIO FREQUENCY. After every case application and before sterilization, always verify visually and manually the condition of both surfaces and edges of the device. For the comfort and safety of the patient during insertion of the ocular shields an ophthalmic topical anaesthetic and ointment (non petroleum based for laser) is recommended. Users must choose a shield size appropriate to the globe. During periorbital surgery the shields should cover the entire globe.
Published
2019-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Product Code Classifications

CodeDeviceSpecialtyClass
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10697660001767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1069766000176710697660001767

GMDN Terms

TermDefinition
Radiation/mechanical corneal shield, reusableA 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 reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length25.5Millimeter
Width23Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
514-381-3292sales@oculoplastik.com

Regulatory Flags

DUNS number
257382580
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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