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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™ - 00849554004641

Prevena Peel & Place Dressing- 13 cm
KCI USA, INC.
Prevena Peel & Place Dressing- 13 cm
In Commercial Distribution

  • 00849554004641 ()
  • 00849554004603 ()
  • 00849554005372 ()


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

V.A.C. VERAT.R.A.C. DUO™ - 00849554001312

VAC Veralink Cassette
KCI USA, INC.
ULTLNK0500
In Commercial Distribution

  • 00849554001312 ()
  • 00849554000186 ()
  • 00849554003231 ()


  • Negative-pressure wound therapy tubing set

COM module for use with the MAC 5500 ST electrocardiograph - 04059358001470

No Description
ergoline GmbH
705780
In Commercial Distribution

  • 04059358001470 ()


  • Bicycle ergometer

Cytal® - 00386190001011

Burn Matrix 5 X 5 cm
ACELL, INC.
BMM0505
Not in Commercial Distribution

  • 00386190001011 ()

  • Rectangle device approximately 5 x 5 cm
BMM0505

  • Animal-derived wound matrix dressing

MatriStem - 00386190000403

Surgical Matrix 5 x 5 cm
ACELL, INC.
PSMX0505
Not in Commercial Distribution

  • 00386190000403 ()

  • Rectangle device approximately 5 x 5 cm
PSMX0505

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

Halyard - 10680651136869

SURGPN,400X2-14+5,PMPSAF,-,OQ,5
Avanos Medical, Inc.
13686
In Commercial Distribution

  • 30680651136863 ()
  • 10680651136869 ()
P400X2-14 plus5

  • Elastomeric infusion pump system

Halyard - 10680651134803

SURGPN,400X5+5,CBI,-,OQ,5
Avanos Medical, Inc.
13480
In Commercial Distribution

  • 30680651134807 ()
  • 10680651134803 ()
CBI003

  • Elastomeric infusion pump system

Phospholin ES w/Calcium - 10859394006238

APTT reagent 5 x 5 ml
R 2 DIAGNOSTICS, INC.
21-405
In Commercial Distribution

  • 10859394006238 ()
  • 00859394006231 ()
21-405

  • Activated partial thromboplastin time (APTT) IVD, reagent

NA - 00810050245425

WEDGE, 5" x 5" x 15"
DOMICO MED-DEVICE, LLC
108-8
Not in Commercial Distribution

  • 00810050245425 ()

  • Height: 5 Inch
  • Width: 5 Inch
  • Length: 15 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner

NA - 00810050244794

WEDGE, 5" x 5" x 15"
DOMICO MED-DEVICE, LLC
108
In Commercial Distribution

  • 00810050244794 ()

  • Height: 5 Inch
  • Width: 5 Inch
  • Length: 15 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
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