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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Berman airway is used to establish the airway and prevent the tongue fall and the airway block.
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
9#
In Commercial Distribution

  • 26946430401087 ()
  • 16946430401080 ()
  • 06946430401083 ()


  • Oropharyngeal airway, single-use
Enterprise
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034120 ()
PLU238

  • Radiology information system application software
US & International
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034110 ()
PLU349

  • Radiology information system application software
Animal
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034090 ()
PLU235

  • Radiology information system application software
Forensic
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034080 ()
PLU236

  • Radiology information system application software
No Description
Chemoment Materials Co., Ltd.
9
In Commercial Distribution

  • 06976009589997 ()


  • Silicone dental impression material
GLASS VAN STAINLESS STEEL STERILE SURGICAL BLADE #9 INDIVIDUALLY PACKED MYCO REORDER # 2003-09
NIRAJ INDUSTRIES PRIVATE LIMITED
#9
In Commercial Distribution

  • 28904233119835 ()
  • 18904233119838 ()
  • 58904233119836 ()
  • 08904233119831 ()
01983

  • Manual scalpel blade, single-use
No Description
Raysearch Laboratories AB (Publ)
9
In Commercial Distribution

  • 07350002010174 ()


  • Radiation therapy software
KIT, RECTANGLE. Includes: 126-00-001 - RECTANGLE, 6" x 4" x .50" (00810050243834), 126-00-002 - RECTANGLE, 6" x 4" x 1 " (00810050243841), 126-00-003 - RECTANGLE, 6" x 4" x 1.50" (00810050243858), 126-00-004 - RECTANGLE, 6" x 4" x 2" (00810050243865)
DOMICO MED-DEVICE, LLC
9
In Commercial Distribution

  • 00810050243933 ()


  • Multifunction body cushion
  • Radiological general body-part positioner
WebPAX® is intended for use in the communication and storage of medical images. WebPAX® is also intended for use as a comprehensive solution to view, optimize, and post-process diagnostic medical images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging examinations.
HEART IMAGING TECHNOLOGIES, LLC
9
In Commercial Distribution

  • B127WP90 ()
n/a

  • Medical image management system
PACS Device
Les Systèmes Médicaux Intelerad Incorporée
9
In Commercial Distribution

  • B228INTELEHEART0 ()


  • Radiological PACS software
GS HIV Combo Ag/Ab EIA, 960 Tests
Bio-RAD Laboratories, Inc.
26218
Not in Commercial Distribution

  • 00847865010665 ()

  • 960 tests
26218

  • HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)
GS HIV Combo Ag/Ab EIA, 192 Tests
Bio-RAD Laboratories, Inc.
26217
Not in Commercial Distribution

  • 00847865010658 ()

  • 192 Tests
26217

  • HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)
Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS. Panthera-Puncher 9 is cabable of handling up to 9 pcs of 96-well microtiter plates simultaneously. Panthera-Puncher contains a camera for imaging of the sample card and for blood detection.
Wallac Oy
2081-0010
In Commercial Distribution

  • 06438147325856 ()
2081-0010

  • Specimen processing instrument IVD
GDWR 9PROV180HS ProVia 5pk 180 HY ST
MEDTRONIC, INC.
9PROV180HS
Not in Commercial Distribution

  • 20643169453054 ()
  • 00643169453050 ()

  • Outer Diameter: 0.014 Inch
  • Length: 180.0 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use
GDWR 9PROV180SS ProVia 5pk 180 Si ST
MEDTRONIC, INC.
9PROV180SS
Not in Commercial Distribution

  • 20643169453047 ()
  • 00643169453043 ()

  • Outer Diameter: 0.014 Inch
  • Length: 180.0 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use
GDWR 9PROV300HS ProVia 5pk 300 HY ST
MEDTRONIC, INC.
9PROV300HS
In Commercial Distribution

  • 20643169453030 ()
  • 00643169453036 ()

  • Outer Diameter: 0.014 Inch
  • Length: 300.0 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use
GDWR 9PROV300SS ProVia 5pk 300 Si ST
MEDTRONIC, INC.
9PROV300SS
In Commercial Distribution

  • 20643169452903 ()
  • 00643169452909 ()

  • Outer Diameter: 0.014 Inch
  • Length: 300.0 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use
No Description
FGX INTERNATIONAL INC.
10252025.KHL
In Commercial Distribution

  • 00193033195819 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252006.KHL
In Commercial Distribution

  • 00193033195802 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252012.KHL
In Commercial Distribution

  • 00193033195796 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252005.KHL
In Commercial Distribution

  • 00193033195789 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252014.KHL
In Commercial Distribution

  • 00193033195772 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252004.KHL
In Commercial Distribution

  • 00193033195765 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252003.KHL
In Commercial Distribution

  • 00193033195758 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252024.KHL
In Commercial Distribution

  • 00193033195741 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252002.KHL
In Commercial Distribution

  • 00193033195734 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252007.KHL
In Commercial Distribution

  • 00193033195727 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252001.KHL
In Commercial Distribution

  • 00193033195710 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252009.KHL
In Commercial Distribution

  • 00193033195703 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252010.KHL
In Commercial Distribution

  • 00193033195697 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252000.KHL
In Commercial Distribution

  • 00193033195680 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252021.KHL
In Commercial Distribution

  • 00193033195673 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10251999.KHL
In Commercial Distribution

  • 00193033195666 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10251998.KHL
In Commercial Distribution

  • 00193033195659 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252016.KHL
In Commercial Distribution

  • 00193033195642 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10251997.KHL
In Commercial Distribution

  • 00193033195635 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10251996.KHL
In Commercial Distribution

  • 00193033195628 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252015.KHL
In Commercial Distribution

  • 00193033195611 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10251995.KHL
In Commercial Distribution

  • 00193033195604 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10251994.KHL
In Commercial Distribution

  • 00193033195598 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252018.KHL
In Commercial Distribution

  • 00193033195581 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10251993.KHL
In Commercial Distribution

  • 00193033195574 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252019.KHL
In Commercial Distribution

  • 00193033195567 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10251992.KHL
In Commercial Distribution

  • 00193033195550 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252013.KHL
In Commercial Distribution

  • 00193033195543 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10251991.KHL
In Commercial Distribution

  • 00193033195536 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10252011.KHL
In Commercial Distribution

  • 00193033195529 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10251990.KHL
In Commercial Distribution

  • 00193033195512 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10251989.KHL
In Commercial Distribution

  • 00193033195505 ()


  • Tinted non-prescription spectacles
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