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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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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

ABTHERA ADVANCE™ - 00849554006966

ABTHERA ADVANCE™ OPEN ABDOMEN DRESSING
KCI USA, INC.
ABT1055
In Commercial Distribution

  • 00849554006966 ()
  • 00849554006942 ()


  • Negative-pressure wound therapy open-abdomen dressing

V.A.C.ULTA™ - 00849554006775

Solution Container Hanger Arm Extension
KCI USA, INC.
ULTEXT0500
Not in Commercial Distribution

  • 00849554006775 ()
  • 00849554006782 ()


  • Frame/rail/pole device holder

PREVENA™ PEEL & PLACE™ - 00849554006416

Prevena Peel & Place Dressing- 35 cm
KCI USA, INC.
Prevena Peel & Place Dressing- 35 cm
In Commercial Distribution

  • 00849554006416 ()
  • 00849554006379 ()


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

V.A.C. VERAFLO Cleanse Choice™ - 00849554006256

V.A.C. VERAFLO Cleanse Choice™ DRESSING LARGE
KCI USA, INC.
ULTVCC05LG
In Commercial Distribution

  • 00849554006263 ()
  • 00849554006256 ()


  • Irrigation negative-pressure wound therapy dressing

V.A.C. ® - 00849554005020

VAC Drape XL
KCI USA, INC.
M6275097/5
Not in Commercial Distribution

  • 00849554005020 ()
  • 00849554005013 ()


  • Negative-pressure wound therapy tubing set

V.A.C.VIA™ - 00849554003156

VAC Via System Starter Kit
KCI USA, INC.
VIAKIT07S05/US
In Commercial Distribution

  • 00849554003156 ()
  • 00849554002449 ()


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

V.A.C.® GRANUFOAM™ - 00849554002579

SENSATRAC, HEEL DRESSING/POUCH
KCI USA, INC.
320913
Not in Commercial Distribution

  • 00849554002579 ()
  • 00849554000858 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

Orabloc - needle stick safety system - 08051040583000

The Needlestick Safety system is designed for safely recapping needles. The device consists of a disk, filled with 100 micro rubber caps, suitable for recapping needles after utilisation, for a safe disposal.
PIERREL SPA
20200707
In Commercial Distribution

  • 08051040583000 ()

  • 100 capsules that fit a range of needle sizes
20200707

  • Needle recapping device, single-use

Henry Schein - H65857003841

Spirette Mouthpiece
HENRY SCHEIN, INC.
5700384
In Commercial Distribution

  • H65857003841 ()
  • H65857003849 ()
5700384

  • Breathing mouthpiece, single-use
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