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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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MULTITECH 3G GATEWAY - ATT KORE - 00883873863077

MULTITECH 3G GATEWAY - ATT KORE
PHYSIO-CONTROL, INC.
21996
Not in Commercial Distribution

  • 00883873863077 ()
21996-000105

  • Emergency/ambulatory healthcare software

MULTITECH 3G GATEWAY - VERIZON - 00883873863060

MULTITECH 3G GATEWAY - VERIZON
PHYSIO-CONTROL, INC.
21996
Not in Commercial Distribution

  • 00883873863060 ()
21996-000106

  • Emergency/ambulatory healthcare software

MULTITECH 3G GATEWAY - VERIZON KORE - 00883873863053

MULTITECH 3G GATEWAY - VERIZON KORE
PHYSIO-CONTROL, INC.
21996
Not in Commercial Distribution

  • 00883873863053 ()
21996-000107

  • Emergency/ambulatory healthcare software

MULTITECH 3G GATEWAY - INTL - 00883873863046

MULTITECH 3G GATEWAY - INTL
PHYSIO-CONTROL, INC.
21996
Not in Commercial Distribution

  • 00883873863046 ()
21996-000108

  • Emergency/ambulatory healthcare software

LIFENET ASSET EXPORT 32-BIT - 00883873862902

LIFENET ASSET EXPORT 32-BIT 5.4.1.2
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873862902 ()
21340-000843

  • Emergency/ambulatory healthcare software

LIFENET ASSET EXPORT 64-BIT - 00883873862896

LIFENET ASSET EXPORT 64-BIT 5.4.1.2
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873862896 ()
21340-000844

  • Emergency/ambulatory healthcare software

LIFENET CONSULT INTERNATIONAL - 00883873863732

LIFENET CONSULT INTERNATIONAL RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873863732 ()
21340-000838

  • Emergency/ambulatory healthcare software

OculoMotor Technologies - 00860012940608

Virtual Eye Rotation Vision Exercises for Convergence Insufficiency Therapy
Oculomotor Technologies Inc.
VERVE
In Commercial Distribution

  • 00860012940608 ()


  • Virtual-display routine exercise software

EarliPoint - 00860009993709

The EarliPoint System is an eye tracking device used as a tool to aid clinicians in the diagnosis and assessment of ASD patients.
Earlitec Diagnostics, Inc.
EPT001
In Commercial Distribution

  • 00860009993709 ()


  • Neurodevelopmental disorder interpretive software

KIDScore D3 - 05712714675317

The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyst stage by scoring them according to their statistical viability. Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing. The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ timelapse incubator systems.
Vitrolife A/S
16531
In Commercial Distribution

  • 05712714675317 ()
16531

  • Assisted reproduction embryo-assessment software
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