FDA.reportPublic FDA data

Argus ll Retinal Implant Kit

Primary DI
00856264005707
Brand
Argus ll Retinal Implant Kit
Company
Second Sight Medical Products, Inc.
Model
011015-002-K
Catalog number
011015-K
Device description
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.
Published
2017-08-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBFProsthesis,Retinal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBFProsthesis, RetinalUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H110002018

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H110002018

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856264005707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856264005707008562640057078562640057070856264005707

GMDN Terms#

Term, Definition table
TermDefinition
Video-camera epiretinal prosthesis system orbital implantA sterile implantable component of a video-camera epiretinal prosthesis system designed to be implanted around and inside the eye for neural stimulation of the retina via an electrode array that is attached to the retina with a retinal tack. It consists of an electronics case, an implant coil, an epiretinal electrode array, and a scleral band, and is powered and receives stimulation commands from a visual processing unit which processes the image from the camera mounted on the spectacles and transforms it into electrical stimulation patterns. The power and commands are transmitted wirelessly to the implant from a coil on the spectacles.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
818-833-5027customerservice@secondsight.com

Regulatory Flags#

DUNS number
086470742
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856264005424Argus ll CA-VPU Cable014913-0010149132015-05-06
00856264005431Argus ll CPS-PTS Cable014915-0010149152015-05-06
00856264005448Argus ll CPS-CA Cable014916-0020149162015-05-06
00856264005455Argus ll Archive Drive014931-0010149312015-05-06
00856264005462Argus ll Touch Screen Monitor014932-0010149322015-05-06
00856264005479Argus ll USB Security Drive014984-0010149842015-05-06
00856264005486Argus ll USB Transfer Drive014985-0010149852015-05-06
00856264005493Argus ll USB Video Settings Drive014986-0010149862015-05-06
00856264005509Argus ll Camera Rotation Tool014993-0000149932015-05-06
00856264005516Argus ll VPU Screwdriver014972-0000149722015-05-06
00856264005523Argus ll Glasses Screwdriver014973-0000149732015-05-06
10856264005322Argus II Retinal Prosthesis Retinal Tacks011006-0010110062014-12-16
00856264005288Argus ll Rentinal Prosthesis Kit, Right Eye011013-002-K011013-K2015-05-06
00856264005295Argus ll Retinal Implant Kit, Right Eye011013-004-K011013-K2015-05-06
00856264005301Argus ll Retinal Implant Kit011014-002-K011014-K2015-05-06
00856264005318Argus ll Retinal Implant Kit011014-004-K011014-K2015-05-06
00856264005332Argus ll Video Processing Unit013003-0040130032015-05-06
00856264005349Argus ll Glasses012012-0030120122015-05-06
00856264005356Argus ll Glasses012011-0030120112015-05-06
00856264005363Argus ll Glasses012014-0030120142015-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850052743055Argus II Communication Adapter (CA)CORTIGENT, INC.NBF2023-06-30
00850052743123Argus II Glasses, Left Eye, Dark LensesCORTIGENT, INC.NBF2023-06-30
00850052743161Argus II Operating Room CoilCORTIGENT, INC.NBF2023-06-30
00850052743000Argus II Video Processing Unit (VPU)CORTIGENT, INC.NBF2023-06-29
00850052743109Argus II Glasses - Right Eye - Dark LensesCORTIGENT, INC.NBF2023-06-29
00850052743116Argus II Glasses, Right Eye, Clear LensesCORTIGENT, INC.NBF2023-06-29
00850052743130Argus II Glasses, Left Eye, Clear LensesCORTIGENT, INC.NBF2023-06-29
00856264005691Argus ll Retinal Implant KitSecond Sight Medical Products, Inc.NBF2017-08-09
00856264005714Argus ll Video Processing UnitSecond Sight Medical Products, Inc.NBF2017-08-09
00856264005721Argus ll Clinician Programming SystemSecond Sight Medical Products, Inc.NBF2017-08-09
00856264005776SwiftPA SoftwareSecond Sight Medical Products, Inc.NBF2017-08-09
00856264005295Argus ll Retinal Implant Kit, Right EyeSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005301Argus ll Retinal Implant KitSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005318Argus ll Retinal Implant KitSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005332Argus ll Video Processing UnitSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005349Argus ll GlassesSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005356Argus ll GlassesSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005363Argus ll GlassesSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005370Argus ll GlassesSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005387Argus ll Operating Room CoilSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005394Argus ll Clinician Programming SystemSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005400Argus ll Communication AdapterSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005417Argus ll Psychophysical Test SystemSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005424Argus ll CA-VPU CableSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005431Argus ll CPS-PTS CableSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005448Argus ll CPS-CA CableSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005455Argus ll Archive DriveSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005462Argus ll Touch Screen MonitorSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005479Argus ll USB Security DriveSecond Sight Medical Products, Inc.NBF2015-05-06
00856264005486Argus ll USB Transfer DriveSecond Sight Medical Products, Inc.NBF2015-05-06