Impressions

GUDID 08806392051260

INTEROJO INC.

Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear Soft corrective contact lens, daily-wear
Primary Device ID08806392051260
NIH Device Record Key96f88633-04ed-439b-854e-2fac16c06a7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameImpressions
Version Model NumberImpressions/True Sapphire
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 Numbertrue
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+1-954-730-9244
Emailrho@interojo.com
Phone+1-954-730-9244
Emailrho@interojo.com
Phone+1-954-730-9244
Emailrho@interojo.com
Phone+1-954-730-9244
Emailrho@interojo.com
Phone+1-954-730-9244
Emailrho@interojo.com
Phone+1-954-730-9244
Emailrho@interojo.com
Phone+1-954-730-9244
Emailrho@interojo.com
Phone+1-954-730-9244
Emailrho@interojo.com
Phone+1-954-730-9244
Emailrho@interojo.com
Phone+1-954-730-9244
Emailrho@interojo.com
Phone+1-954-730-9244
Emailrho@interojo.com
Phone+1-954-730-9244
Emailrho@interojo.com
Phone+1-954-730-9244
Emailrho@interojo.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108806392051192 [Primary]
GS108806392051192 [Primary]
GS108806392051192 [Primary]
GS108806392051192 [Primary]
GS108806392051192 [Primary]
GS108806392051192 [Primary]
GS108806392051192 [Primary]
GS108806392051192 [Primary]
GS108806392051192 [Primary]
GS108806392051192 [Primary]
GS108806392051192 [Primary]
GS108806392051192 [Primary]
GS108806392051192 [Primary]
GS108806392051260 [Unit of Use]
GS108806392051260 [Unit of Use]
GS108806392051260 [Unit of Use]
GS108806392051260 [Unit of Use]
GS108806392051260 [Unit of Use]
GS108806392051260 [Unit of Use]
GS108806392051260 [Unit of Use]
GS108806392051260 [Unit of Use]
GS108806392051260 [Unit of Use]
GS108806392051260 [Unit of Use]
GS108806392051260 [Unit of Use]
GS108806392051260 [Unit of Use]
GS108806392051260 [Unit of Use]

FDA Product Code

LPLLenses, Soft Contact, Daily Wear
LPLLenses, Soft Contact, Daily Wear
LPLLenses, Soft Contact, Daily Wear
LPLLenses, Soft Contact, Daily Wear
LPLLenses, Soft Contact, Daily Wear
LPLLenses, Soft Contact, Daily Wear
LPLLenses, Soft Contact, Daily Wear
LPLLenses, Soft Contact, Daily Wear
LPLLenses, Soft Contact, Daily Wear
LPLLenses, Soft Contact, Daily Wear
LPLLenses, Soft Contact, Daily Wear
LPLLenses, Soft Contact, Daily Wear
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 Date2020-09-14
Device Publish Date2020-09-04

On-Brand Devices [Impressions]

08806392051239Impressions/Hazel
08806392051222Impressions/Green
08806392051215Impressions/Gray
08806392051208Impressions/Brown
08806392051260Impressions/True Sapphire
08806392051253Impressions/Pure Hazel
08806392051246Impressions/Honey

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.