ZonedIn Contact Lenses 610350

GUDID 00810040141393

Daily wear soft contact lens -3.50 power

ZONEDIN VISION, LLC

Soft corrective contact lens, daily-disposable
Primary Device ID00810040141393
NIH Device Record Key7234b85f-cfa4-4e21-9765-3cd56ad687d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameZonedIn Contact Lenses
Version Model Number610350
Catalog Number610350
Company DUNS117142079
Company NameZONEDIN VISION, LLC
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810040141393 [Primary]
GS100810040143014 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MVNLens, contact, (disposable)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-12
Device Publish Date2019-12-04

On-Brand Devices [ZonedIn Contact Lenses]

00810040142154Daily wear soft contact lens trial +6.00 power
00810040142147Daily wear soft contact lens trial +5.50 power
00810040142130Daily wear soft contact lens trial +5.00 power
00810040142123Daily wear soft contact lens trial +4.50 power
00810040142116Daily wear soft contact lens trial +4.00 power
00810040142109Daily wear soft contact lens trial +3.75 power
00810040142093Daily wear soft contact lens trial +3.50 power
00810040142086Daily wear soft contact lens trial +3.25 power
00810040142079Daily wear soft contact lens trial +3.00 power
00810040142062Daily wear soft contact lens trial +2.75 power
00810040142055Daily wear soft contact lens trial +2.50 power
00810040142048Daily wear soft contact lens trial +2.25 power
00810040142031Daily wear soft contact lens trial +2.00 power
00810040142024Daily wear soft contact lens trial +1.75 power
00810040142017Daily wear soft contact lens trial +1.50 power
00810040142000Daily wear soft contact lens trial +1.25 power
00810040141997Daily wear soft contact lens trial +1.00 power
00810040141980Daily wear soft contact lens trial +0.75 power
00810040141973Daily wear soft contact lens trial +0.50 power
00810040141966Daily wear soft contact lens trial -12.00 power
00810040141959Daily wear soft contact lens trial -11.50 power
00810040141942Daily wear soft contact lens trial -11.00 power
00810040141935Daily wear soft contact lens trial -10.50 power
00810040141928Daily wear soft contact lens trial -10.00 power
00810040141911Daily wear soft contact lens trial -9.50 power
00810040141904Daily wear soft contact lens trial -9.00 power
00810040141898Daily wear soft contact lens trial -8.50 power
00810040141881Daily wear soft contact lens trial -8.00 power
00810040141874Daily wear soft contact lens trial -7.50 power
00810040141867Daily wear soft contact lens trial -7.00 power
00810040141850Daily wear soft contact lens trial -6.50 power
00810040141843Daily wear soft contact lens trial -6.00 power
00810040141836Daily wear soft contact lens trial -5.75 power
00810040141829Daily wear soft contact lens trial -5.50 power
00810040141812Daily wear soft contact lens trial -5.25 power
00810040141805Daily wear soft contact lens trial -5.00 power
00810040141799Daily wear soft contact lens trial -4.75 power
00810040141782Daily wear soft contact lens trial -4.50 power
00810040141775Daily wear soft contact lens trial -4.25 power
00810040141768Daily wear soft contact lens trial -4.00 power
00810040141751Daily wear soft contact lens trial -3.75 power
00810040141744Daily wear soft contact lens trial -3.50 power
00810040141737Daily wear soft contact lens trial -3.25 power
00810040141720Daily wear soft contact lens trial -3.00 power
00810040141713Daily wear soft contact lens trial -2.75 power
00810040141706Daily wear soft contact lens trial -2.50 power
00810040141690Daily wear soft contact lens trial -2.25 power
00810040141683Daily wear soft contact lens trial -2.00 power
00810040141676Daily wear soft contact lens trial -1.75 power
00810040141669Daily wear soft contact lens trial -1.50 power

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