ProOcular Daily Disposable Contact Lens

GUDID 40816816880624

ProOcular Daily Disposable Contact Lens Power -8.5

CARLSBAD TECHNOLOGY INC.

Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable Soft corrective contact lens, daily-disposable
Primary Device ID40816816880624
NIH Device Record Key213914b2-878f-4816-a795-91549de4cc8b
Commercial Distribution Discontinuation2019-12-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameProOcular Daily Disposable Contact Lens
Version Model Number-8.5
Company DUNS079113545
Company NameCARLSBAD TECHNOLOGY INC.
Device Count30
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-397-9777
Emailservice@carlsbadtech.com
Phone1-855-397-9777
Emailservice@carlsbadtech.com
Phone1-855-397-9777
Emailservice@carlsbadtech.com
Phone1-855-397-9777
Emailservice@carlsbadtech.com
Phone1-855-397-9777
Emailservice@carlsbadtech.com
Phone1-855-397-9777
Emailservice@carlsbadtech.com
Phone1-855-397-9777
Emailservice@carlsbadtech.com
Phone1-855-397-9777
Emailservice@carlsbadtech.com
Phone1-855-397-9777
Emailservice@carlsbadtech.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100816816880626 [Unit of Use]
GS110816816880623 [Primary]
GS130816816880627 [Package]
Contains: 10816816880623
Package: Case [24 Units]
Discontinued: 2019-12-01
Not in Commercial Distribution
GS140816816880624 [Package]
Contains: 30816816880627
Package: Carton [6 Units]
Discontinued: 2019-12-01
Not in Commercial Distribution

FDA Product Code

MVNLens, Contact, (Disposable)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-09-20
Device Publish Date2016-10-28

On-Brand Devices [ProOcular Daily Disposable Contact Lens]

40816816880655ProOcular Daily Disposable Contact Lens Power -10
40816816880648ProOcular Daily Disposable Contact Lens Power -9.5
40816816880631ProOcular Daily Disposable Contact Lens Power -9
40816816880624ProOcular Daily Disposable Contact Lens Power -8.5
40816816880617ProOcular Daily Disposable Contact Lens Power -8
40816816880600ProOcular Daily Disposable Contact Lens Power -7.5
40816816880594ProOcular Daily Disposable Contact Lens Power -7
40816816880587ProOcular Daily Disposable Contact Lens Power -6.5
40816816880570ProOcular Daily Disposable Contact Lens Power -6
40816816880563ProOcular Daily Disposable Contact Lens Power -5.75
40816816880556ProOcular Daily Disposable Contact Lens Power -5.5
40816816880549ProOcular Daily Disposable Contact Lens Power -5.25
40816816880532ProOcular Daily Disposable Contact Lens Power -5
40816816880525ProOcular Daily Disposable Contact Lens Power -4.75
40816816880518ProOcular Daily Disposable Contact Lens Power -4.5
40816816880501ProOcular Daily Disposable Contact Lens Power -4.25
40816816880495ProOcular Daily Disposable Contact Lens Power -4
40816816880488ProOcular Daily Disposable Contact Lens Power -3.75
40816816880471ProOcular Daily Disposable Contact Lens Power -3.5
40816816880464ProOcular Daily Disposable Contact Lens Power -3.25
40816816880457ProOcular Daily Disposable Contact Lens Power -3
40816816880440ProOcular Daily Disposable Contact Lens Power -2.75
40816816880433ProOcular Daily Disposable Contact Lens Power -2.5
40816816880426ProOcular Daily Disposable Contact Lens Power -2.25
40816816880419ProOcular Daily Disposable Contact Lens Power -2
40816816880402ProOcular Daily Disposable Contact Lens Power -1.75
40816816880396ProOcular Daily Disposable Contact Lens Power -1.5
10816816880388ProOcular Daily Disposable Contact Lens Power -1.25
10816816880371ProOcular Daily Disposable Contact Lens power -1.0

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