HD

GUDID 08806392000206

INTEROJO INC.

Soft corrective contact lens, daily-wear
Primary Device ID08806392000206
NIH Device Record Key792447dd-27c5-4adc-9e5f-2c74c15d600e
Commercial Distribution Discontinuation2020-01-29
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHD
Version Model NumberHD2
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
Emailrho@interojo.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108806392000206 [Primary]
GS108806392000213 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-03
Device Publish Date2019-12-18

On-Brand Devices [HD]

08806392000794HDX2
08806392000206HD2
08806392040783HD

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