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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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ASSURE, Garment, Style A, Size 4 - 00840241600085

The Style A, 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.
80015-004
In Commercial Distribution

  • 00840241600085 ()

  • Style A, Size 4
80015-004

  • Wearable defibrillation system defibrillator

ASSURE, Garment, Style A, Size 3 - 00840241600078

The Style A, 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.
80015-003
In Commercial Distribution

  • 00840241600078 ()

  • Style A, Size 3
80015-003

  • Wearable defibrillation system defibrillator

ASSURE, Garment, Style A, Size 2 - 00840241600061

The Style A, 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.
80015-002
In Commercial Distribution

  • 00840241600061 ()

  • Style A, Size 2
80015-002

  • Wearable defibrillation system defibrillator

ASSURE, Garment, Style A, Size 1 - 00840241600054

The Style A, 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.
80015-001
In Commercial Distribution

  • 00840241600054 ()

  • Style A, Size 1
80015-001

  • Wearable defibrillation system defibrillator

MIX A Kit - 00858637005505

No Description
EXACT SCIENCES CORPORATION
100309
In Commercial Distribution

  • 00858637005505 ()


  • Nucleic acid amplification mastermix kit IVD

Model 2504 Maestro Clinician Programmer Kit - 00857334004361

The Model 2504 Clinician Programmer Kit consists of a Model 2502 Clinician Programmer, a Model 2402 Mobile Charger, a Model 2403-300 Clinician Transmit Coil, a Model 1620 AC Recharger, and a Model 1600 Programmer Cable that are packaged together.
Reshape Lifesciences Inc.
2504
Not in Commercial Distribution

  • 00857334004361 ()
2504

  • Vagus nerve electrical stimulation system programmer

Bulkamid - 05704101500500

Bulkamid Urethral Bulking System
Contura International A/S
50050
In Commercial Distribution

  • 05704101500500 ()


  • Urological surgical procedure kit, non-medicated, single-use

MarginProbe® Probe - 07290012534034

The probe is a detachable, sterile, single-use, single-patient component with a 3-year shelf life. It is connected to the console by two RF cables and a vacuum tube, via a single connector.
DILON MEDICAL TECHNOLOGIES LTD
AC0300001
In Commercial Distribution

  • 07290012534034 ()


  • Intraoperative tumour margin analysis probe

MarginProbe® Probe - 07290012534010

The probe is a detachable, sterile, single-use, single-patient component with a 3-year shelf life. It is connected to the console by two RF cables and a vacuum tube, via a single connector.
DUNE MEDICAL DEVICES LTD
AC0300001
In Commercial Distribution

  • 07290012534010 ()


  • Intraoperative tumour margin analysis probe

Profemur - M684PHA012441

PROFEMUR NECK 15DG A/R LONG
Microport Orthopedics Inc.
PHA01244
In Commercial Distribution

  • PHA01244 ()
  • M684PHA012441 ()

  • Length: 2.172 Millimeter
PHA01244

  • Press-fit hip femur prosthesis, modular
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