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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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V.A.C. VERAFLO™ - 00849554001299

Vac Veraflo Dressing System Small
KCI USA, INC.
ULTVFL05SM
In Commercial Distribution

  • 00849554001299 ()
  • 00849554000148 ()


  • Irrigation negative-pressure wound therapy dressing

ABTHERA™ SENSAT.R.A.C.™ - 00849554001282

Abthera Open Abdomen Dressing with Sensatrac pad
KCI USA, INC.
M8275026/5
In Commercial Distribution

  • 00849554001282 ()
  • 00849554000216 ()


  • Negative-pressure wound therapy open-abdomen dressing

ABTHERA™ - 00849554001275

Abthera Tubing Set
KCI USA, INC.
370642
In Commercial Distribution

  • 00849554001275 ()
  • 00849554000230 ()


  • Negative-pressure wound therapy tubing set

ABTHERA™ - 00849554001268

Abthera Open Abdomen Dressing
KCI USA, INC.
370605
In Commercial Distribution

  • 00849554001268 ()
  • 00849554000223 ()


  • Negative-pressure wound therapy open-abdomen dressing

CELLUTOME™ - 00849554001220

Cellutome Epidermal Harvesting System Harvester (5.0cm)
KCI USA, INC.
CT-H50
In Commercial Distribution

  • 00849554001220 ()
  • 00849554001206 ()


  • Dermatome handpiece, electrically-powered

CELLUTOME™ - 00849554001213

Cellutome Epidermal Harvesting System Harvester (2.5cm)
KCI USA, INC.
CT-H25
In Commercial Distribution

  • 00849554001213 ()
  • 00849554001190 ()


  • Dermatome handpiece, electrically-powered

PREVENA™ CUSTOMIZABLE™ - 00849554000087

Prevena Customizable Dressing
KCI USA, INC.
Prevena Customizable Dressing
In Commercial Distribution

  • 00849554000087 ()
  • 00849554000070 ()


  • Negative-pressure wound therapy system, electric, single-use

PREVENA™ - 00849554000032

Prevena 45 ml canister
KCI USA, INC.
Prevena 45 ml canister
In Commercial Distribution

  • 00849554000032 ()
  • 00849554000025 ()


  • Negative-pressure wound therapy system, electric, single-use

PREVENA™ PEEL & PLACE™ - 00849554000018

Prevena Peel & Place Dressing- 20 cm Prevena Patch Strips
KCI USA, INC.
Prevena Peel & Place Dressing- 20 cm
In Commercial Distribution

  • 00849554000018 ()
  • 00849554000131 ()


  • Negative-pressure wound therapy system, electric, single-use

CardioWrap® - 08964050362025

Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). Indicated for use as a pericardium replacement device in patients that may require re-operation within six months.
MAST BIOSURGERY USA INC.
100 x 130 x 0.02mm
Not in Commercial Distribution

  • 18964050362022 ()
  • 08964050362025 ()

  • Length: 130 Millimeter
  • Width: 100 Millimeter
  • Thickness: 0.02 Millimeter
36202-01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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