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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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DGR - M454CS55A0UVP1551

POSTERIOR CHAMBER INTRAOCULAR LENS
EYEKON MEDICAL, INC.
CS55A-0UV-15.5
In Commercial Distribution

  • M454CS55A0UVP1551 ()


  • Posterior-chamber intraocular lens, pseudophakic

DGR - M454CS55A0UVP1501

POSTERIOR CHAMBER INTRAOCULAR LENS
EYEKON MEDICAL, INC.
CS55A-0UV-15.0
In Commercial Distribution

  • M454CS55A0UVP1501 ()


  • Posterior-chamber intraocular lens, pseudophakic

CES-Ultra - M750AR635A0

Cranial Electrotherapy Stimulator
NEURO-FITNESS LLC
AR635A
In Commercial Distribution

  • M750AR635A0 ()
CES-Ultra

  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system

CES-Ultra - M750AR635A

Cranial Electrotherapy Stimulator
NEURO-FITNESS LLC
AR635A
In Commercial Distribution

  • M750AR635A ()
CES-Ultra

  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system

Saver EVO - M727SAVEREVOH013

Saver EVO is a user friendly information management program to assist users to manage data from their defibrillation device. Saver EVO shall allow the user to download the data from a HeartSine device to a PC computer. Saver EVO™ data management software enables downloading, revie wing and printing ECG waveforms and event history data recorded in HeartSine samaritan PAD devices. Features of Saver EVO include:Comprehensive event documentation to facilitate physician oversight, Utstein style reporting and report export capabilities, User configuration setup and time synchronization, Simple point-and-click operation
HEARTSINE TECHNOLOGIES LTD
1.4.0
In Commercial Distribution

  • M727SAVEREVOH013 ()
PAD-ACC-03

  • External defibrillator application software

samaritan PAD - M727SAM360P0

Fully Automatic Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM360P
In Commercial Distribution

  • M727SAM360P0 ()


  • Non-rechargeable public automated external defibrillator

samaritan PAD - M727SAM350P

Semi-Automatic External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 350P
In Commercial Distribution

  • M727SAM350P ()


  • Non-rechargeable public semi-automated external defibrillator

Pad-Pak - M727PADPAK07

Combined Battery and Electrode Cartridge. Accessory to a therapeutic medical device in the range of Automated External Defibrillators.
HEARTSINE TECHNOLOGIES LTD
Pad-Pak-07
In Commercial Distribution

  • M727PADPAK07 ()
Pad-Pak-07

  • Non-rechargeable public semi-automated external defibrillation electrode, adult

Pediatric-Pak - M727PADPAK02

Combined Battery and Electrode Cartridge. Accessory to a therapeutic medical device in the range of Automated External Defibrillators.
HEARTSINE TECHNOLOGIES LTD
Pad-Pak-02
In Commercial Distribution

  • M727PADPAK02 ()
Pad-Pak-02

  • Non-rechargeable public semi-automated external defibrillation electrode, paediatric

Pad-Pak - M727PADPAK01

Combined Battery and Electrode Cartridge. Accessory to a therapeutic medical device in the range of Automated External Defibrillators.
HEARTSINE TECHNOLOGIES LTD
Pad-Pak-01
In Commercial Distribution

  • M727PADPAK01 ()
Pad-Pak-01

  • Non-rechargeable public semi-automated external defibrillation electrode, adult
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