FDA.reportPublic FDA data

Eye Cups

Primary DI
00616784338002
Brand
Eye Cups
Company
Dynarex Corporation
Model
3380
Device description
Eye Cups in Sealed Vial
Published
2022-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXQCup, Eye

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXQCup, EyeUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151575000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151575000Dynarex Eye CupsDynarex Corporation2015-09-01LXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784338019PackageGS16In Commercial Distribution
00616784338033PackageGS150In Commercial Distribution
00616784338002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784338019006167843380196167843380190616784338019
00616784338033006167843380336167843380330616784338033
00616784338002006167843380026167843380020616784338002

GMDN Terms#

Term, Definition table
TermDefinition
Eye wash cupA receptacle designed to fit around the eye socket and which is filled with warm water or an eyewash solution and placed over the eye to allow the liquid to wash the affected eye. It is typically used as a first line measure when dust or other particles have inadvertently entered the eye. It is usually made of plastic, glass or a ceramic material and is intended for use in the home, in a clinical setting, or for hospitalized or institutionalized patients. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784711720Disposable Ear Specula Tips For Diagnostic Otoscopes, Adult, 4.25 mm71172021-05-21
00616784418025Bandage Shears 7.5" (19.1 cm) Black41802020-11-08
00616784418124Bandage Shears 7.5" (19.1 cm) Blue41812020-11-08
00616784418223Bandage Shears 7.5" (19.1 cm) Magenta41822020-11-08
00616784418322Bandage Shears 7.5" (19.1 cm) Orange41832020-11-08
00616784418421Bandage Shears 7.5" (19.1 cm) Purple41842020-11-08
00616784418520Bandage Shears 7.5" (19.1 cm) Red41852020-11-08
00616784418629Bandage Shears 7.5" (19.1 cm) Teal41862020-11-08
00616784418728Bandage Shears 7.5" (19.1 cm) Yellow41872020-11-08
00616784419022Mini Scissors 4" (10.2 cm) Red41902020-11-08
00616784419121Bandage Shears 5.5" (14.0 cm) Black41912020-11-08
00616784419220Bandage Shears 5.5" (14.0 cm) Blue41922020-11-08
00616784419329Bandage Shears 5.5" (14.0 cm) Magenta41932020-11-08
00616784419428Bandage Shears, 5.5" (14.0 cm) Orange41942020-11-08
00616784419527Bandage Shears 5.5" (14.0 cm) Purple41952020-11-08
00616784419626Bandage Shears, 5.5" (14.0 cm) Red41962020-11-08
00616784419725Bandage Shears, 5.5" (14.0 cm) Teal41972020-11-08
00616784419824Bandage Shears,5.5" (14.0 cm) Yellow41982020-11-08
00616784711522PA SensiLance Pressure Activated Safety Lancets,Sterile71152021-05-21
00616784711621Disposable Ear Specula Tips, For Diagnostic Otoscopes, 2.5 mm, Pediatric71162021-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00025715683546FlentsAPOTHECARY PRODUCTS, LLCLXQ2020-09-21
20025715683540FlentsAPOTHECARY PRODUCTS, LLCLXQ2020-09-21