FDA.reportPublic FDA data

Autoclavable Plastic Ocular Shield, bilateral, small, black

Primary DI
10697660002788
Brand
Autoclavable Plastic Ocular Shield, bilateral, small, black
Company
Oculo-Plastik Inc
Model
23-202B
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

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10697660002788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1069766000278810697660002788

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length26Millimeter
Width23.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
514-381-3292sales@oculoplastik.com

Regulatory Flags#

DUNS number
257382580
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10697660003617Autoclavable Plastic Sterilisation Tray with mat, large27-10061512019-11-28
10697660003631Autoclavable Plastic Sterilisation Tray with mat27-1006752019-11-28
10697660003686Autoclavable Plastic Sterilisation Tray with mat, medium27-65452019-11-11
10697660003679Autoclavable Plastic Sterilisation Tray with mat, small27-65302019-11-07
10697660002191David-Baker,Stainless Steel Lid Clamp for the Laser, small (non glare)21-3222019-11-18
10697660002207David-Baker,Stainless Steel Lid Clamp for the Laser, small (non glare), refurb.21-322R2019-11-18
10697660002221David-Baker,Stainless Steel Lid Clamp for the Laser, regular (non glare)21-3232019-11-18
10697660002245David-Baker,Stainless Steel Lid Clamp for the Laser, regular (non glare), refurb21-323R2019-11-18
M87221416V95Symblepharon Ring Conformer Large, In Bulk21-416V2016-10-16
10697660001903Sutcliffe SS Shield & Retractor for the Laser (flat) (non glare), refurb .21-275R2019-11-21
10697660001927Sutcliffe SS Shield & Retractor for the Laser (bent) (non glare), refurb.21-276R2019-11-21
10697660001965Sutcliffe Boey SS Laser Shield with all holes in one (non glare), refurb.21-287R2019-11-21
10697660001989Laser SWAB SS Tissue Handler And Backstop for Laser (non glare)21-2892019-11-21
10697660001996Laser SWAB SS Tissue Handler And Backstop for Laser (non glare), refurb.21-289R2019-11-21
10697660002023Khan-Jaeger SS Lid Plate for the Laser (non glare), refurb.21-292R2019-11-21
10697660002047Jaeger SS Lid Plate for the Laser (non glare), refurb.21-295R2019-11-21
10697660003297Plastic Jaeger lid plates, t-yellow more concave model with small & medium ends23-293Y2019-11-25
10697660003310Plastic Jaeger lid plates, t-yellow flater model with medium & large ends23-295Y2019-11-25
10697660003334Desmarres, Autoclavable plastic retractor t-yellow23-311Y2019-11-25
10697660003341Desmarres, Autoclavable plastic retractor t-yellow23-315Y2019-11-25

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