FDA.report

Autoclavable Plastic Ocular Shield, bilateral, medium, black

Primary DI
10697660002955
Brand
Autoclavable Plastic Ocular Shield, bilateral, medium, black
Company
Oculo-Plastik Inc
Model
23-204BE
Device description
The plastic ocular shields are used to protect the eyes when working with a scalpel, electro-cutter or other energy sources requiring protective plastic shields as the metal would be conductive (ex: RF system). The ocular shields are inserted under the eyelids over the globe, and remain in place for the duration of the intervention. They should not be left in place more than 60 minutes. PLASTIC OCULAR SHIELDS ARE NOT INTENDED FOR USE WITH LASER OR IPL SYSTEMS.
Published
2019-11-05
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
10697660002955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1069766000295510697660002955

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
Length27.5Millimeter
Width24.5Millimeter

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
true
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
true
Sterilization required before use
true

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10697660003457Castroviejo Suturing Forceps (0.5 mm)25-1052019-11-21
10697660003464Castroviejo Suturing Forceps (0.5 mm), refurb.25-105R2019-11-21
10697660003471Castroviejo Suturing Forceps (0.9 mm)25-1092019-11-21
10697660003488Castroviejo Suturing Forceps (0.9 mm), refurb.25-109R2019-11-21
10697660003495Castroviejo Suturing Forceps (1.2 mm)25-1122019-11-21
10697660003501Castroviejo Suturing Forceps (1.2 mm), refurb.25-112R2019-11-21
10697660003518Castroviejo Caliper (non glare)25-1402019-11-21

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