Impression

GUDID 08806392000046

INTEROJO INC.

Soft corrective contact lens, daily-wear
Primary Device ID08806392000046
NIH Device Record Key9b261822-1fb3-419e-9aa8-c420bc469942
Commercial Distribution Discontinuation2020-01-29
Commercial Distribution StatusNot in Commercial Distribution
Brand NameImpression
Version Model NumberImpression/Gray
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+1-954-730-9244
Email[email protected]

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108806392000046 [Primary]
GS108806392000053 [Unit of Use]

FDA Product Code

LPLLenses, Soft Contact, Daily Wear

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-03
Device Publish Date2019-12-18

On-Brand Devices [Impression]

08806392000145Impression/True Sapphire
08806392000121Impression/Pure Hazel
08806392000107Impression/Honey
08806392000084Impression/Hazel
08806392000060Impression/Green
08806392000046Impression/Gray
08806392000022Impression/Brown
08806392040066Impression/True Sapphire
08806392040059Impression/Pure Hazel
08806392040042Impression/Honey
08806392040035Impression/Hazel
08806392040028Impression/Green
08806392040011Impression/Gray
08806392040004Impression/Brown

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