FDA.reportPublic FDA data

Argus ll Operating Room Coil

Primary DI
00856264005387
Brand
Argus ll Operating Room Coil
Company
Second Sight Medical Products, Inc.
Model
012103-003
Catalog number
012103
Device description
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.
Published
2015-05-06
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
H110002003

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H110002003

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856264005387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856264005387008562640053878562640053870856264005387

GMDN Terms#

Term, Definition table
TermDefinition
Retinal prosthesis system implantation test coilA radio-frequency coil that is a component of a retinal prosthesis system designed for intraoperative testing of the implant. Typically it is used in the operating room (OR) by a surgeon 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
818-833-5023customerservice@secondsight.com

Regulatory Flags#

DUNS number
086470742
Device count
1
Serial number
true
Manufacturing 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
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
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