Eye Cups

GUDID 00616784338002

Eye Cups in Sealed Vial

DYNAREX CORPORATION

Eye wash cup
Primary Device ID00616784338002
NIH Device Record Keye157dc79-4f39-4314-9b3c-d9ae46e5299f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEye Cups
Version Model Number3380
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784338002 [Primary]
GS100616784338019 [Package]
Package: Vial [6 Units]
In Commercial Distribution
GS100616784338033 [Package]
Contains: 00616784338019
Package: Case [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXQCup, Eye

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-03
Device Publish Date2022-04-25

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