PolyVue HD Dailies

GUDID 08806392040080

INTEROJO INC.

Soft corrective contact lens, daily-disposable
Primary Device ID08806392040080
NIH Device Record Key43a6f395-16e0-440e-ba64-110e6cb90576
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolyVue HD Dailies
Version Model NumberHD Dailies
Company DUNS688455799
Company NameINTEROJO INC.
Device Count90
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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-760-754-2220
Email[email protected]

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108806392040080 [Primary]
GS108806392040202 [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 Date2020-02-11
Device Publish Date2020-02-03

On-Brand Devices [PolyVue HD Dailies]

08806392000770HD Dailies
08806392040080HD Dailies

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