HDX2

GUDID 08806392040097

INTEROJO INC.

Soft corrective contact lens, daily-wear
Primary Device ID08806392040097
NIH Device Record Key60802446-5ddc-4777-91f3-64dbd970e010
Commercial Distribution StatusIn Commercial Distribution
Brand NameHDX2
Version Model NumberHDX2
Company DUNS688455799
Company NameINTEROJO INC.
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 Usefalse
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
GS108806392040097 [Primary]
GS108806392040219 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPLLenses, Soft Contact, Daily Wear

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

Devices Manufactured by INTEROJO INC.

08806392040790 - HDX2020-02-11
08806392040783 - HD2020-02-11
08806392040110 - Top Model2020-02-11
08806392040103 - Festival2020-02-11
08806392040097 - HDX22020-02-11
08806392040097 - HDX22020-02-11
08806392040080 - PolyVue HD Dailies2020-02-11
08806392040073 - HD22020-02-11
08806392040066 - Impression2020-02-11

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