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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Argus ll USB Video Settings Drive - 00856264005493

USB thumb drive containing video settings that can be loaded to the Video Processing Unit.
Second Sight Medical Products, Inc.
014986-001
Not in Commercial Distribution

  • 00856264005493 ()
014986

  • Retinal prosthesis system tester/clinical evaluator

Argus ll USB Transfer Drive - 00856264005486

USB thumb drive for transferring selected files from the Clinician Programming System laptop for data analysis.
Second Sight Medical Products, Inc.
014985-001
Not in Commercial Distribution

  • 00856264005486 ()
014985

  • Retinal prosthesis system tester/clinical evaluator

Argus ll USB Security Drive - 00856264005479

USB thumb drive loaded with security files that contain encrypted login information to enable clinician’s access to the Clinician Programming System laptop.
Second Sight Medical Products, Inc.
014984-001
Not in Commercial Distribution

  • 00856264005479 ()
014984

  • Retinal prosthesis system tester/clinical evaluator

Argus ll Touch Screen Monitor - 00856264005462

Used during the camera alignment procedure or other tests to record the patient’s responses.
Second Sight Medical Products, Inc.
014932-001
Not in Commercial Distribution

  • 00856264005462 ()
014932

  • Retinal prosthesis system tester/clinical evaluator

Argus ll Archive Drive - 00856264005455

External USB Drive for archiving of files from the Clinician Programming System laptop.
Second Sight Medical Products, Inc.
014931-001
Not in Commercial Distribution

  • 00856264005455 ()
014931

  • Retinal prosthesis system tester/clinical evaluator

Argus ll CPS-CA Cable - 00856264005448

Cable that connects the Clinician Programming System to the Communication Adapter during programming of the Retinal Prosthesis.
Second Sight Medical Products, Inc.
014916-002
Not in Commercial Distribution

  • 00856264005448 ()
014916

  • Retinal prosthesis system tester/clinical evaluator

Argus ll CPS-PTS Cable - 00856264005431

Cable that connects the Clinician Programming System to the Psychophysical Test System during programming of the Retinal Prosthesis.
Second Sight Medical Products, Inc.
014915-001
Not in Commercial Distribution

  • 00856264005431 ()
014915

  • Retinal prosthesis system tester/clinical evaluator

Argus ll CA-VPU Cable - 00856264005424

Cable that connects the Communication Adapter to the Video Processing Unit during programming of Retinal Prosthesis.
Second Sight Medical Products, Inc.
014913-001
Not in Commercial Distribution

  • 00856264005424 ()
014913

  • Retinal prosthesis system tester/clinical evaluator

Argus ll Communication Adapter - 00856264005400

A device which provides data communication and electrical isolation between the Video Processing Unit and the Clinician Programming System.
Second Sight Medical Products, Inc.
014103-002
Not in Commercial Distribution

  • 00856264005400 ()
014103

  • Retinal prosthesis system tester/clinical evaluator

Argus ll Clinician Programming System - 00856264005394

Laptop computer that is configured with dedicated, PC-based software that, when connected to the Video Processing Unit, enables programming of the electrical stimulation parameters of the implant.
Second Sight Medical Products, Inc.
014003-004-R
Not in Commercial Distribution

  • 00856264005394 ()
014003

  • Retinal prosthesis system tester/clinical evaluator

Alpine BioMed - 00673978212043

ACTIVE HANDGRIP FOR KP G3
Alpine Biomed ApS
9031E0153
Not in Commercial Distribution

  • 00673978212043 ()


  • Electromyograph

Alpine BioMed - 00673978206998

4 CH. AMP BOX/ARM KEYPOINT
Alpine Biomed ApS
9031C0312
Not in Commercial Distribution

  • 00673978206998 ()


  • Electromyograph

Alpine BioMed - 00673978206981

2 CHANNEL EMG/EP AMPLI-
Alpine Biomed ApS
9031C0302
Not in Commercial Distribution

  • 00673978206981 ()


  • Electromyograph

VistaPhone - 00850490007481

Vista Phone S9 relay device
Vital Connect, Inc.
8303-03
In Commercial Distribution

  • 00850490007481 ()
8303-03

  • Multiple vital physiological parameter monitoring system transceiver

Alpine BioMed - 05704736019859

FOCUS MAIN UNIT
Alpine Biomed ApS
9033G0704
Not in Commercial Distribution

  • 05704736019859 ()


  • Electromyograph

Alpine BioMed - 05704736019477

"Keypoint Focus Module: CN Including: - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Module kit including Keypoint software CD"
Alpine Biomed ApS
9033A0701CN
Not in Commercial Distribution

  • 05704736019477 ()


  • Electromyograph

Alpine BioMed - 05704736019408

Macro Stimulator
Alpine Biomed ApS
9031E0752
Not in Commercial Distribution

  • 05704736019408 ()


  • Electromyograph

Alpine BioMed - 05704736019330

ACTIVE HANDGRIP FOR KP G3
Alpine Biomed ApS
9031E0155
Not in Commercial Distribution

  • 05704736019330 ()


  • Electromyograph

Alpine BioMed - 05704736019170

Cable kit for Focus Main Unit
Alpine Biomed ApS
9033A1801
Not in Commercial Distribution

  • 05704736019170 ()


  • Electromyograph

Alpine BioMed - 05704736019163

KP FOCUS PC SYSTEM, UK 230V SPECIAL LABELING FOR CHINA
Alpine Biomed ApS
9033A0721CN
Not in Commercial Distribution

  • 05704736019163 ()


  • Electromyograph
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