Argus ll Rentinal Prosthesis Kit, Right Eye

Primary DI
00856264005288
Brand
Argus ll Rentinal Prosthesis Kit, Right Eye
Company
Second Sight Medical Products, Inc.
Model
011013-002-K
Catalog number
011013-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
2015-05-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H110002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H110002000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856264005288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856264005288008562640052888562640052880856264005288

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit

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
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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
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
00856264005370Argus ll Glasses012013-0030120132015-05-06