Argus ll Operating Room Coil 012103

GUDID 00856264005387

The operating room coil is used during surgery in replacement of the glasses. A telemetry coil and radio-frequency system are mounted on the device to provide communication between the implant and the VPU during surgery.

Second Sight Medical Products, Inc.

Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil Retinal prosthesis system implantation test coil

• Primary Device ID: 00856264005387
• NIH Device Record Key: dfa6440d-5ddd-4883-bad1-a20a3c23db42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Argus ll Operating Room Coil
• Version Model Number: 012103-003
• Catalog Number: 012103
• Company DUNS: 086470742
• Company Name: Second Sight Medical Products, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com
• Phone: 818-833-5023
• Email: customerservice@secondsight.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856264005387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H110002

FDA Product Code

• NBF: Prosthesis,Retinal

Sterilization

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

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: 2018-07-06 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