FDA.report

Wink-Ease

Primary DI
00089937555678
Brand
Wink-Ease
Company
Lt Acquisition, Inc.
Model
Lash Room
Published
2022-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

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
00089937000031PrimaryGS10
00089937000048PrimaryGS10
00089937990127PrimaryGS10
00089937555678Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00089937000031000899370000310899370000310089937000031
00089937000048000899370000480899370000480089937000048
00089937990127000899379901270899379901270089937990127
00089937555678000899375556780899375556780089937555678

GMDN Terms

TermDefinition
Epiocular radiation shield, single-useAn 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 single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
054375491
Device count
250
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00089937000055Wink EaseClassic 250ct2022-05-10
00089937000079Wink EaseLash Room Ultra Gold Sample Pack 50ct2022-05-10
00089937554565LA TanUltra Gold 50ct2022-05-10
00089937999014Wink-EaseUltra Gold2022-05-02

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