Argus ll Rentinal Prosthesis Kit, Right Eye 011013-K

GUDID 00856264005288

The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrically stimulating the retina to induce visual perception.

Second Sight Medical Products, Inc.

Video-camera epiretinal prosthesis system orbital implant

• Primary Device ID: 00856264005288
• NIH Device Record Key: 34d8338f-db91-47de-82eb-df81066993bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Argus ll Rentinal Prosthesis Kit, Right Eye
• Version Model Number: 011013-002-K
• Catalog Number: 011013-K
• Company DUNS: 086470742
• Company Name: Second Sight Medical Products, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com
• Phone: 818-833-5027
• Email: customerservice@secondsight.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856264005288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H110002

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-05-06

Devices Manufactured by Second Sight Medical Products, Inc.

• 10856264005322 - Argus II Retinal Prosthesis Retinal Tacks: 2023-05-18 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 Eye: 2018-07-06The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrically stimulating the retina to induce visual perception.
• 00856264005288 - Argus ll Rentinal Prosthesis Kit, Right Eye: 2018-07-06 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 Eye: 2018-07-06 The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrica
• 00856264005301 - Argus ll Retinal Implant Kit: 2018-07-06 The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrica
• 00856264005318 - Argus ll Retinal Implant Kit: 2018-07-06 The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrica
• 00856264005332 - Argus ll Video Processing Unit: 2018-07-06 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 Glasses: 2018-07-06 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 Glasses: 2018-07-06 The Argus II Glasses provide a convenient and discreet way to house the video camera for capturing images and the radio-frequenc