Menicon Unique pH Multi-Purpose Solution

GUDID 00853253003058

MENICON AMERICA, INC.

Multi-purpose rigid contact lens solution
Primary Device ID00853253003058
NIH Device Record Key958c80aa-a8da-4bfe-8047-315fe3ca04b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMenicon Unique pH Multi-Purpose Solution
Version Model NumberStarter Kit
Company DUNS034212507
Company NameMENICON AMERICA, INC.
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853253003058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRCProducts, Contact Lens Care, Rigid Gas Permeable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-20
Device Publish Date2016-09-23

On-Brand Devices [Menicon Unique pH Multi-Purpose Solution]

00853253003065Travel Pack
00853253003058Starter Kit
00853253003003120mL

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