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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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Arterial cannula for children Ø 12/9 mm; L 28 cm; angle 85°
Berlin Heart GmbH
C85G-004
In Commercial Distribution

  • 04260090040348 ()

  • Lumen/Inner Diameter: 12 Millimeter


  • External ventricular circulatory assist system
Arterial cannula for children Ø 12/9 mm; L 28 cm; angle 60°
Berlin Heart GmbH
C60G-004
In Commercial Distribution

  • 04260090040331 ()

  • Lumen/Inner Diameter: 12 Millimeter


  • External ventricular circulatory assist system
Rapid fFN® test cassettes for the TLI IQ® system, 26 count.
Hologic, Inc.
KIT, RAPID FFN 26 CASSETTE TLIIQ SYSTEM
In Commercial Distribution

  • 25420045501154 ()
  • 15420045501157 ()
01200

  • Fibronectin IVD, kit, enzyme immunohistochemistry
ExAblate 2100 LOWER PELVIC COIL ASSEMBLY for MRI imaging during Body FUS treatments.
INSIGHTEC LTD
ASM000506-AA ExAblate 2100 LOWER PELVIC COIL ASSEMBLY
In Commercial Distribution

  • 07290015461498 ()
ASM000506-AA

  • Therapeutic oncological/gynaecological ultrasound system
Single use kit for cleaning the product after a Neuro V2 clinical treatment
INSIGHTEC LTD
SET000961 Neuro V2 cleaning kit
In Commercial Distribution

  • 07290015461443 ()
SET000961

  • Therapeutic oncological/gynaecological ultrasound system
Prolapse Repair System - Anterior
Coloplast A/S
50100
In Commercial Distribution

  • 05708932459457 ()
50100

  • Suturing unit, single-use
  • Female stress urinary incontinence surgical mesh-sling, synthetic polymer
Prolapse Repair System - Posterior
Coloplast A/S
50150
In Commercial Distribution

  • 05708932459433 ()
50150

  • Suturing unit, single-use
  • Female stress urinary incontinence surgical mesh-sling, synthetic polymer
PXB35-10-57-135 STENT VISI PRO 035 V01
Covidien LP
PXB35-10-57-135
In Commercial Distribution

  • 00643169788060 ()

  • Max. Guidewire .89 MM
  • Outer Diameter: 10.0 Millimeter
  • Catheter Gauge: 7.0 French
  • Length: 57.0 Millimeter


  • Peripheral artery stent, bare-metal
PXB35-10-57-080 STENTVISI PRO 035 V01
Covidien LP
PXB35-10-57-080
In Commercial Distribution

  • 00643169788053 ()

  • Outer Diameter: 10.0 Millimeter
  • Max. Guidewire .89 MM
  • Length: 57.0 Millimeter
  • Catheter Gauge: 7.0 French


  • Peripheral artery stent, bare-metal
PXB35-10-37-135 STENT VISI PRO 035 V01
Covidien LP
PXB35-10-37-135
In Commercial Distribution

  • 00643169788046 ()

  • Catheter Gauge: 7.0 French
  • Outer Diameter: 10.0 Millimeter
  • Max. Guidewire .89 MM
  • Length: 37.0 Millimeter


  • Peripheral artery stent, bare-metal
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