Argus ll Archive Drive 014931

GUDID 00856264005455

External USB Drive for archiving of files from the Clinician Programming System laptop.

Second Sight Medical Products, Inc.

Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator Retinal prosthesis system tester/clinical evaluator
Primary Device ID00856264005455
NIH Device Record Key9654400e-5128-422d-8544-fdca89897500
Commercial Distribution StatusIn Commercial Distribution
Brand NameArgus ll Archive Drive
Version Model Number014931-001
Catalog Number014931
Company DUNS086470742
Company NameSecond Sight Medical Products, Inc.
Device Count1
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com
Phone818-833-5027
Emailcustomerservice@secondsight.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100856264005455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBFProsthesis,Retinal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-05-06

Devices Manufactured by Second Sight Medical Products, Inc.

10856264005322 - Argus II Retinal Prosthesis Retinal Tacks2023-05-18 The Argus II Retinal Tack is used to affix the electrode array of the Retinal Prosthesis to the retina.
00856264005288 - Argus ll Rentinal Prosthesis Kit, Right Eye2018-07-06 The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrica
00856264005295 - Argus ll Retinal Implant Kit, Right Eye2018-07-06 The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrica
00856264005301 - Argus ll Retinal Implant Kit2018-07-06 The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrica
00856264005318 - Argus ll Retinal Implant Kit2018-07-06 The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrica
00856264005332 - Argus ll Video Processing Unit2018-07-06 The VPU is used to process the images from the video camera (on the Glasses) and convert the images into electrical stimulation
00856264005349 - Argus ll Glasses2018-07-06 The Argus II Glasses provide a convenient and discreet way to house the video camera for capturing images and the radio-frequenc
00856264005356 - Argus ll Glasses2018-07-06 The Argus II Glasses provide a convenient and discreet way to house the video camera for capturing images and the radio-frequenc

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