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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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Integra® Dermal Regeneration Template - 10381780000556

INTEGRA Dermal Regeneration Template 2in. x 2in. (5cm x 5cm) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound.
Integra Lifesciences Corporation
32025
In Commercial Distribution

  • M269320251 ()
  • 10381780000556 ()
  • 00381780000559 ()

  • 2 in x 2 in
32025

  • Collagen wound matrix dressing

XVIVO Organ Chamber™ - 07350069520074

The XVIVO Organ Chamber™ is intended to be used as a temporary receptacle for isolated donor lungs in preparation for eventual transplantation into a recipient.
Xvivo Perfusion AB
19020
In Commercial Distribution

  • 07350069520074 ()
19020

  • Lung donor-organ preservation/evaluation system lung-interface set

REFORM - 00380652257046

REFORM CAPSULAR TENSION RING 13.0/11MM The ALCON ReFORM Capsular Tension Ring is a sterile, non-optical ocular implant, manufactured from a single piece of PMMA(POlymethylmethacrylate).
Alcon Laboratories, Inc.
8065225704
In Commercial Distribution

  • 00380652257046 ()

  • Outer diameter compressed 11.0 MM
  • Outer Diameter: 13.0 Millimeter


  • Capsular tension ring

REFORM - 00380652257039

REFORM CAPSULAR TENSION RING 12.3/10MM The ALCON ReFORM Capsular Tension Ring is a sterile, non-optical ocular implant, manufactured from a single piece of PMMA(POlymethylmethacrylate).
Alcon Laboratories, Inc.
8065225703
In Commercial Distribution

  • 00380652257039 ()

  • Outer diameter compressed : 10.0 Millimeter
  • Outer Diameter: 12.3 Millimeter
ACTR10

  • Capsular tension ring

Eversense Mobile App iOS - 00817491023520

Eversense Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-02-300
In Commercial Distribution

  • 00817491023520 ()
FG-5501-02-300

  • Implantable glucose monitoring system

REFORM - 00380652257053

REFORM CAPS T RING 14.5/12MM The ALCON ReFORM Capsular Tension Ring is a sterile, non-optical ocular implant, manufactured from a single piece of PMMA(POlymethylmethacrylate).
Alcon Laboratories, Inc.
8065225705
In Commercial Distribution

  • 00380652257053 ()

  • Outer diameter compressed : 12.0 Millimeter
  • Outer Diameter: 14.5 Millimeter


  • Capsular tension ring

Nit-Occlud PDA - 04042301160034

Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.
pfm medical ag
145116V2
In Commercial Distribution

  • 4042301160041 ()
  • 04042301160034 ()

  • 11 x 6
145116V2

  • Cardiac defect occluder

Nit-Occlud PDA - 04042301159991

Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.
pfm medical ag
145076V2
In Commercial Distribution

  • 4042301160003 ()
  • 04042301159991 ()

  • 7 x 6
145076V2

  • Cardiac defect occluder

Nit-Occlud PDA - 04042301159977

Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.
pfm medical ag
145065V2
In Commercial Distribution

  • 4042301159984 ()
  • 04042301159977 ()

  • 6 x 5
145065V2

  • Cardiac defect occluder

Nit-Occlud PDA - 04042301159939

Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.
pfm medical ag
145044V2
In Commercial Distribution

  • 04042301159939 ()
  • 4042301159946 ()

  • 4 x 4
145044V2

  • Cardiac defect occluder
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