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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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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

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

Synchron - 15099590221256

CAL 5 PLUS Calibrator 5 Plus
Beckman Coulter, Inc.
469975
In Commercial Distribution

  • 15099590221256 ()
469975

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

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

No Description
ergoline GmbH
705780
In Commercial Distribution

  • 04059358001470 ()


  • Bicycle ergometer

VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container, com - 07640172552438

VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container, complete
icotec AG
42-700
In Commercial Distribution

  • 07640172552438 ()
42-700

  • Device sterilization/disinfection container, reusable

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

SURGUARD2 - 34806017512942

SURGUARD2 Safety Hypodermic Needle
TERUMO (PHILIPPINES) CORPORATION
10180094
In Commercial Distribution

  • 54806017512946 ()
  • 34806017512942 ()
  • 14806017512948 ()

  • Needle Gauge: 27 Gauge
  • Length: 0.5 Inch


  • Hypodermic needle, single-use

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
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