FDA.reportPublic FDA data

Durette® III, regular, refurb.

Primary DI
10697660002467
Brand
Durette® III, regular, refurb.
Company
Oculo-Plastik Inc
Model
21-445R
Device description
Stainless Steel Eye Cups for Durette® III, regular (non glare) (refurbished)This stainless steel (surface treated) eye wear covers all wavelengths. USE ONLY WITH PURE LASERS OR PURE IPL SYSTEMS. DO NOT USE WITH SYSTEMS THAT ARE INTEGRATED WITH ELECTRIC CURRENT.
Published
2019-11-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IWSShield, Eye, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWSShield, Eye, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10697660002467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1069766000246710697660002467

GMDN Terms#

Term, Definition table
TermDefinition
Epiocular radiation shield, reusableAn 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.

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
Premarket exempt
true
Combination product
true
Lot or batch
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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