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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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Acculink™ - 08717648076206

RX ACCULINK™ Carotid Stent System 5.0 mm x 40 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011337-40
In Commercial Distribution

  • 08717648076206 ()
1011337-40

  • Bare-metal carotid artery stent

Acculink™ - 08717648076190

RX ACCULINK™ Carotid Stent System 5.0 mm x 30 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011337-30
In Commercial Distribution

  • 08717648076190 ()
1011337-30

  • Bare-metal carotid artery stent

LC PowerCel™ Adapter - 00840094448957

No Description
Advanced Bionics, LLC
CI-2000
In Commercial Distribution



  • Electrical mains power cable

ASSURE, Garment, Style B, Size 6 - 00840241600177

The Style B, Size 6, 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.
80016-006
In Commercial Distribution

  • 00840241600177 ()

  • Style B, Size 6
80016-006

  • Wearable defibrillation system defibrillator

ASSURE, Garment, Style B, Size 5 - 00840241600160

The Style B, Size 5, 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.
80016-005
In Commercial Distribution

  • 00840241600160 ()

  • Style B, Size 5
80016-005

  • Wearable defibrillation system defibrillator

ASSURE, Garment, Style B, Size 4 - 00840241600153

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

ASSURE, Garment, Style B, Size 3 - 00840241600146

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

ASSURE, Garment, Style B, Size 2 - 00840241600139

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

ASSURE, Garment, Style B, Size 1 - 00840241600122

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

ASSURE, Garment, Style A, Size 7 - 00840241600115

The Style A, Size 7, 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.
80015-007
In Commercial Distribution

  • 00840241600115 ()

  • Style A, Size 7
80015-007

  • Wearable defibrillation system defibrillator
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