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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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The Style B, Size 4, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.
Kestra Medical Technologies, Inc.
80016-004
In Commercial Distribution

  • 00840241600153 ()

  • Style B, Size 4
80016-004

  • Wearable defibrillation system defibrillator
The Style B, Size 3, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.
Kestra Medical Technologies, Inc.
80016-003
In Commercial Distribution

  • 00840241600146 ()

  • Style B, Size 3
80016-003

  • Wearable defibrillation system defibrillator
The Style B, Size 2, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.
Kestra Medical Technologies, Inc.
80016-002
In Commercial Distribution

  • 00840241600139 ()

  • Style B, Size 2
80016-002

  • Wearable defibrillation system defibrillator
The Style B, Size 1, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.
Kestra Medical Technologies, Inc.
80016-001
In Commercial Distribution

  • 00840241600122 ()

  • Style B, Size 1
80016-001

  • Wearable defibrillation system defibrillator
VIDAS® TPSA is a In Vitro Diagnostic kit for the quantitative detection of total prostate specific antigen (PSA) in human serum, using an enzyme immunoassay (EIA) method.
BIOMERIEUX SA
TPSA
Not in Commercial Distribution

  • 03573026156985 ()
30428-01

  • Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA)
Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Guide, Eversense E3 CGM Quick Reference Guide, and a wallet card.
SENSEONICS, INCORPORATED
FG-5902-01-001
In Commercial Distribution

  • 00817491022936 ()
FG-5902-01-001

  • Implantable glucose monitoring system transmitter
Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Guide, Eversense E3 CGM Quick Reference Guide, and a wallet card.
SENSEONICS, INCORPORATED
FG-5901-01-001
In Commercial Distribution

  • 00817491022929 ()
FG-5901-01-001

  • Implantable glucose monitoring system transmitter
Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Guide, Eversense E3 CGM Quick Reference Guide, and a wallet card.
SENSEONICS, INCORPORATED
FG-5900-01-001
In Commercial Distribution

  • 00817491022912 ()
FG-5900-01-001

  • Implantable glucose monitoring system transmitter
XVIVO Lung Cannula Set II™ is a sterile, single-use set intended to be used to connect isolated donor lungs to an extracorporeal perfusion system for ex-vivo assessment.
Xvivo Perfusion AB
19023
Not in Commercial Distribution

  • 07350069520500 ()
19023

  • Lung donor-organ preservation/evaluation system lung-interface set
Surgical Instrument Guide pin used during OPRA™ Fixture removal. Provides a guiding system to centre the Trephine aligned to the Fixture when used together with Guide Sleeve.
Integrum AB
2617
In Commercial Distribution

  • 07340152102225 ()


  • Internal-external leg prosthesis osseointegration bar
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