FDA.reportPublic FDA data

Argus II Communication Adapter (CA)

Primary DI
00850052743055
Brand
Argus II Communication Adapter (CA)
Company
CORTIGENT, INC.
Model
014103-002
Catalog number
014103
Device description
A device which provides data communication and electrical isolation between the Video Processing Unit and the Clinician Programming System.
Published
2023-06-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
H110002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H110002000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856264005400PreviousGS10
00850052743055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856264005400008562640054008562640054000856264005400
00850052743055008500527430558500527430550850052743055

GMDN Terms#

Term, Definition table
TermDefinition
Retinal prosthesis system tester/clinical evaluatorA component of a retinal prosthesis system designed to perform diagnostic tests of the system, measure patient response to stimulation, and configure the system stimulation parameters and video processing strategies for each patient. It consists of laptop computer, dedicated software, and a communication adaptor. It is used in medical facilities and clinical research settings and is operated by a clinician or other healthcare personnel.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature32 Degrees Fahrenheit113 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18188335027customerservice@cortigent.com

Regulatory Flags#

DUNS number
118946135
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850052743123Argus II Glasses, Left Eye, Dark Lenses012013-0030120132023-06-30
00850052743161Argus II Operating Room Coil012103-0030121032023-06-30
00850052743000Argus II Video Processing Unit (VPU)013003-0060130032023-06-29
00850052743109Argus II Glasses - Right Eye - Dark Lenses012011-0030120112023-06-29
00850052743116Argus II Glasses, Right Eye, Clear Lenses012012-0030120122023-06-29
00850052743130Argus II Glasses, Left Eye, Clear Lenses012014-0030120142023-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00856264005707Argus 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