Head-Up-Display, HUD-1 SA-06427

GUDID 00813125016838

HUD-1, Final Assembly, IRIDEX

IRIDEX CORPORATION

Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display monitor, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour Image display unit, colour
Primary Device ID00813125016838
NIH Device Record Key90152dc3-7001-42c3-939e-cc2370f3db10
Commercial Distribution StatusIn Commercial Distribution
Brand NameHead-Up-Display, HUD-1
Version Model NumberHead-Up-Display, HUD-1
Catalog NumberSA-06427
Company DUNS612920785
Company NameIRIDEX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com
Phone+1(650)940-4700
EmailPASCALService@iridex.com

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100813125016838 [Primary]

FDA Product Code

HOSProjector, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-13
Device Publish Date2021-12-05

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