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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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WebPAX® - B127WP90

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

RayStation - 07350002010174

No Description
Raysearch Laboratories AB (Publ)
9
In Commercial Distribution

  • 07350002010174 ()


  • Radiation therapy software

NA - 00810050243933

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

Ever One - 06946430401267

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

  • 26946430401261 ()
  • 16946430401264 ()
  • 06946430401267 ()


  • Oropharyngeal airway, single-use

EVER READY FIRST AID - 06946430401083

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

GLASS VAN - 18904233119838

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

Chemoment - 06976009589997

No Description
Chemoment Materials Co., Ltd.
9
In Commercial Distribution

  • 06976009589997 ()


  • Silicone dental impression material

DEXIS™ Software - EKAV101034120

Enterprise
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034120 ()
PLU238

  • Radiology information system application software

DEXIS™ Software - EKAV101034110

US & International
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034110 ()
PLU349

  • Radiology information system application software

DEXIS™ Software - EKAV101034090

Animal
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034090 ()
PLU235

  • Radiology information system application software

DEXIS™ Software - EKAV101034080

Forensic
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034080 ()
PLU236

  • Radiology information system application software

GS - 00847865010665

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 - 00847865010658

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)

ProVia 9 - 00643169453036

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

ProVia 9 - 00643169453050

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

ProVia 9 - 00643169453043

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

ProVia 9 - 00643169452909

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

Panthera-Puncher 9 - 06438147325856

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

ATAL 9 - 08809378240061

ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel detect. A built-in a-Si TFT flat panel type digital sensor receives X-Ray and converts to digital image. X-Ray photons are converted to digital output signals. The digital signals are then read out by TFTs. The image data file is saved at the computer for display, which can be linked with PACS and printed by DICOM printer through acquisition software. It is specifically designed to deliver X-Ray imaging for medical, veterinary and industrial applications.
PIXXGEN Corporation
ATAL 9 (Battery Pack)
In Commercial Distribution

  • 08809378240061 ()


  • Indirect flat panel x-ray detector

ATAL 9 - 08809378240054

ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel detect. A built-in a-Si TFT flat panel type digital sensor receives X-Ray and converts to digital image. X-Ray photons are converted to digital output signals. The digital signals are then read out by TFTs. The image data file is saved at the computer for display, which can be linked with PACS and printed by DICOM printer through acquisition software. It is specifically designed to deliver X-Ray imaging for medical, veterinary and industrial applications.
PIXXGEN Corporation
ATAL 9 (ATCB-9)
In Commercial Distribution

  • 08809378240054 ()


  • Indirect flat panel x-ray detector

ATAL 9 - 08809378240047

ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel detect. A built-in a-Si TFT flat panel type digital sensor receives X-Ray and converts to digital image. X-Ray photons are converted to digital output signals. The digital signals are then read out by TFTs. The image data file is saved at the computer for display, which can be linked with PACS and printed by DICOM printer through acquisition software. It is specifically designed to deliver X-Ray imaging for medical, veterinary and industrial applications.
PIXXGEN Corporation
ATAL 9 (Portable Detector)
In Commercial Distribution

  • 08809378240047 ()


  • Indirect flat panel x-ray detector

ATAL 9 - 08809378240030

ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel detect. A built-in a-Si TFT flat panel type digital sensor receives X-Ray and converts to digital image. X-Ray photons are converted to digital output signals. The digital signals are then read out by TFTs. The image data file is saved at the computer for display, which can be linked with PACS and printed by DICOM printer through acquisition software. It is specifically designed to deliver X-Ray imaging for medical, veterinary and industrial applications. ATTENTION
PIXXGEN Corporation
ATAL 9 (Wireless Detector)
In Commercial Distribution

  • 08809378240030 ()


  • Indirect flat panel x-ray detector

ATAL 9 - 08809378240023

ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel detect. A built-in a-Si TFT flat panel type digital sensor receives X-Ray and converts to digital image. X-Ray photons are converted to digital output signals. The digital signals are then read out by TFTs. The image data file is saved at the computer for display, which can be linked with PACS and printed by DICOM printer through acquisition software. It is specifically designed to deliver X-Ray imaging for medical, veterinary and industrial applications.
PIXXGEN Corporation
ATAL 9 (Wired Detector)
In Commercial Distribution

  • 08809378240023 ()


  • Indirect flat panel x-ray detector

CLIP 9 - 03661624006600

Titanium Hemostatic Clip - Small Size
VITALITEC SURGICAL
R9324
Not in Commercial Distribution

  • 03661624006600 ()
  • 03661624005207 ()
  • 03661624006495 ()

  • Height: 3.6 Millimeter
R9324

  • Ligation clip, metallic

CLIP 9 - 03661624006594

Titanium Hemostatic Clip - Medium Size
VITALITEC SURGICAL
B9324
Not in Commercial Distribution

  • 03661624006594 ()
  • 03661624005221 ()
  • 03661624006532 ()

  • Height: 5.6 Millimeter
B9324

  • Ligation clip, metallic

CLIP 9 - 03661624006587

Titanium Hemostatic Clip - Small Size
VITALITEC SURGICAL
J9324
Not in Commercial Distribution

  • 03661624006587 ()
  • 03661624005184 ()
  • 03661624006464 ()

  • Height: 3.6 Millimeter
J9324

  • Ligation clip, metallic

CLIP 9 - 03661624004835

Titanium Hemostatic Clip - Large Size
VITALITEC SURGICAL
O9120
Not in Commercial Distribution

  • 03661624006556 ()
  • 03661624004842 ()
  • 03661624004835 ()

  • Height: 12.3 Millimeter
O9120

  • Ligation clip, metallic

CLIP 9 - 03661624004811

Titanium Hemostatic Clip - Medium/Large Size
VITALITEC SURGICAL
V9120
Not in Commercial Distribution

  • 03661624006549 ()
  • 03661624004828 ()
  • 03661624004811 ()

  • Height: 9.0 Millimeter
V9120

  • Ligation clip, metallic

CLIP 9 - 03661624004774

Titanium Hemostatic Clip - Medium Size
VITALITEC SURGICAL
B9180
Not in Commercial Distribution

  • 03661624006518 ()
  • 03661624004781 ()
  • 03661624004774 ()

  • Height: 5.6 Millimeter
B9180

  • Ligation clip, metallic

CLIP 9 - 03661624004750

Titanium Hemostatic Clip - Small/Medium Size
VITALITEC SURGICAL
L9180
Not in Commercial Distribution

  • 03661624006501 ()
  • 03661624004767 ()
  • 03661624004750 ()

  • Height: 4.7 Millimeter
L9180

  • Ligation clip, metallic

CLIP 9 - 03661624004712

Titanium Hemostatic Clip
VITALITEC SURGICAL
R9180
Not in Commercial Distribution

  • 03661624006471 ()
  • 03661624004729 ()
  • 03661624004712 ()

  • Height: 3.6 Millimeter
R9180

  • Ligation clip, metallic

CLIP 9 - 03661624004675

Titanium Hemostatic Clip - Small Size
VITALITEC SURGICAL
J9180
Not in Commercial Distribution

  • 03661624006440 ()
  • 03661624004682 ()
  • 03661624004675 ()

  • Height: 3.6 Millimeter
J9180

  • Ligation clip, metallic

CLIP 9 - 03661624004651

Titanium Hemostatic Clip - Micro Size
VITALITEC SURGICAL
W9060
Not in Commercial Distribution

  • 03661624006433 ()
  • 03661624004668 ()
  • 03661624004651 ()

  • Height: 2.6 Millimeter
W9060

  • Ligation clip, metallic

APT 9 - 00193033407837

No Description
FGX INTERNATIONAL INC.
10258924.KHL
In Commercial Distribution

  • 00193033407837 ()


  • Tinted non-prescription spectacles

APT 9 - 00193033407783

No Description
FGX INTERNATIONAL INC.
10258934.KHL
In Commercial Distribution

  • 00193033407783 ()


  • Tinted non-prescription spectacles

APT 9 - 00193033407738

No Description
FGX INTERNATIONAL INC.
10258928.KHL
In Commercial Distribution

  • 00193033407738 ()


  • Tinted non-prescription spectacles

APT 9 - 00193033407714

No Description
FGX INTERNATIONAL INC.
10258920.KHL
In Commercial Distribution

  • 00193033407714 ()


  • Tinted non-prescription spectacles

APT 9 - 00193033407691

No Description
FGX INTERNATIONAL INC.
10258923.KHL
In Commercial Distribution

  • 00193033407691 ()


  • Tinted non-prescription spectacles

APT 9 - 00193033407677

No Description
FGX INTERNATIONAL INC.
10258921.KHL
In Commercial Distribution

  • 00193033407677 ()


  • Tinted non-prescription spectacles

APT 9 - 00193033407653

No Description
FGX INTERNATIONAL INC.
10258927.KHL
In Commercial Distribution

  • 00193033407653 ()


  • Tinted non-prescription spectacles
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