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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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AADCO - 00840348508567

LONG MULTI-FIT SHIELD
AADCO MEDICAL, INC.
S-300L
In Commercial Distribution

  • 00840348508567 ()
S-300L

  • Radiation shielding panel, portable/mobile

AADCO - 00840348508550

MULTI FIT SHIELD
AADCO MEDICAL, INC.
S-300
In Commercial Distribution

  • 00840348508550 ()
S-300

  • Radiation shielding panel, portable/mobile

Hercules - 00840348502244

6.3KG SPRING ARM & MOBLIE STAND
AADCO MEDICAL, INC.
OS-800
In Commercial Distribution

  • 00840348502244 ()
OS-800

  • Radiation shielding panel, portable/mobile

Hercules - 00840348501841

ADJUST-A-HEIGHT PIVOTING OVER-TABLE BARRIER DUAL CUTOUT
AADCO MEDICAL, INC.
OS-615D
In Commercial Distribution

  • 00840348501841 ()
OS-615D

  • Radiation shielding panel, portable/mobile

Hercules - 00840348501834

ADJUST-A-HEIGHT PIVOTING OVER TABLE BARRIER WITH CUTOUT
AADCO MEDICAL, INC.
OS-615
In Commercial Distribution

  • 00840348501834 ()
OS-615

  • Radiation shielding panel, portable/mobile

PORTA SHIELD - 00840186698253

PTSSHIELD4 (DRAPE ONLY PORTA SHIELD PTS4 36"L X 24' W RL GREY V), .5mm Regular Lead
BURLINGTON MEDICAL, LLC
PTSSHIELD4
In Commercial Distribution

  • 00840186698253 ()


  • Radiation shielding panel, portable/mobile

PORTA SHIELD - 00840186698246

PTSSHIELD3 (DRAPE ONLY FOR PORTA SHIELD PTS3 48"L X 24"W), .5mm Regular Lead
BURLINGTON MEDICAL, LLC
PTSSHIELD3
In Commercial Distribution

  • 00840186698246 ()


  • Radiation shielding panel, portable/mobile

PORTA SHIELD - 00840186698239

PTSSHIELD2 (DRAPE ONLY FOR PORTA SHIELD PTS2 36"L X 24'W), .5mm Regular Lead
BURLINGTON MEDICAL, LLC
PTSSHIELD2
In Commercial Distribution

  • 00840186698239 ()


  • Radiation shielding panel, portable/mobile

PORTA SHIELD - 00840186698222

PTSSHIELD1 (DRAPE ONLY FOR PORTA SHIELD PTS1 24"L X 24"), .5mm Regular Lead
BURLINGTON MEDICAL, LLC
PTSSHIELD1
In Commercial Distribution

  • 00840186698222 ()


  • Radiation shielding panel, portable/mobile

THALES - 08054890480154

The detector is suitable for acquiring digital images in radiography modes. It allows radiological diagnostic examinations to be performed in real time. The acquired images are saved in the system memory, displayed on a high definition monitor (HD) and eventually transmitted to a diagnostic workstation. An intermediate storage of images is performed if a wireless connection is not available.
GENERAL MEDICAL MERATE SPA
Pixium 3543EZ
In Commercial Distribution

  • 08054890480154 ()


  • Indirect flat panel x-ray detector

THALES - 08054890480147

The detector is suitable for acquiring digital images in radiography modes. It allows radiological diagnostic examinations to be performed in real time. The acquired images are saved in the system memory, displayed on a high definition monitor (HD) and eventually transmitted to a diagnostic workstation. An intermediate storage of images is performed if a wireless connection is not available.
GENERAL MEDICAL MERATE SPA
Pixium 2430EZ
In Commercial Distribution

  • 08054890480147 ()


  • Indirect flat panel x-ray detector

ADD - 08800070400050

The ADD is a Flat Panel Digital X-ray Detector which have 425.04 x 425.6mm (HAD1717MCW) or 345.24 x 425.6mm (HAD1417MCW) effective pixel area. The device communicates by the wired Ethernet and wireless Wi-Fi communication feature. The detector should be integrated with a Console PC and a X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic (the Console PC and X-Ray Generator are not provided from H&Abyz). The ADD consists of the following components: Flat Panel Detector, power supply box, switch box, cable, battery, and battery recharger.
H&abyz Co., Ltd
HAD1717MCW
In Commercial Distribution

  • 08800070400050 ()
HAD1717MCW

  • Indirect flat panel x-ray detector

F1417MCW - 08800070400043

The A1717MCW/A1417MCW/F1417MCW is a Flat Panel Digital X-ray Detector which have 425.04 x 425.6mm (A1717MCW) or 345.24 x 425.6mm (A1417MCW/F1417MCW) effective pixel area. The device communicates by the wired Ethernet and wireless Wi-Fi communication feature. The detector should be integrated with a Console PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic (the Console PC and X-Ray Generator are not provided from H&abyz). The A1717MCW/A1417MCW/F1417MCW consists of the following components: Flat Panel Detector, power supply box, cable, battery, and battery recharger.
H&abyz Co., Ltd
F1417MCW
In Commercial Distribution

  • 08800070400043 ()


  • Indirect flat panel x-ray detector

A1417MCW - 08800070400036

The A1717MCW/A1417MCW/F1417MCW is a Flat Panel Digital X-ray Detector which have 425.04 x 425.6mm (A1717MCW) or 345.24 x 425.6mm (A1417MCW/F1417MCW) effective pixel area. The device communicates by the wired Ethernet and wireless Wi-Fi communication feature. The detector should be integrated with a Console PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic (the Console PC and X-Ray Generator are not provided from H&abyz). The A1717MCW/A1417MCW/F1417MCW consists of the following components: Flat Panel Detector, power supply box, cable, battery, and battery recharger.
H&abyz Co., Ltd
A1417MCW
In Commercial Distribution

  • 08800070400036 ()


  • Indirect flat panel x-ray detector

A1717MCW - 08800070400029

The A1717MCW/A1417MCW/F1417MCW is a Flat Panel Digital X-ray Detector which have 425.04 x 425.6mm (A1717MCW) or 345.24 x 425.6mm (A1417MCW/F1417MCW) effective pixel area. The device communicates by the wired Ethernet and wireless Wi-Fi communication feature. The detector should be integrated with a Console PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic (the Console PC and X-Ray Generator are not provided from H&abyz). The A1717MCW/A1417MCW/F1417MCW consists of the following components: Flat Panel Detector, power supply box, cable, battery, and battery recharger.
H&abyz Co., Ltd
A1717MCW
In Commercial Distribution

  • 08800070400029 ()


  • Indirect flat panel x-ray detector

HAD1717MC - 08800070400012

The HAD1717MC is a wired digital flat panel X-ray detector. The HAD1717MC X-ray detector consists of a TFT panel and a scintillator electronic controller, and supports AED (Automatic Exposure Detection) function that can operate without a separate trigger signal. Flat panel sensors for HAD1717MC are fabricated using thin film technology based on amorphous silicon technology, and the sensors are similar to existing photodiode arrays. In this case, each pixel is composed of a photodiode and a thin film transistor (TFT). Amorphous silicon photodiodes are optimized for green wavelengths and can be used in combination with scintillators such as CsI. The incident X-rays are converted into visible light by the scintillator, and the visible light is stored in an internal capacitor through a photodiode. Charges charged to capacitors switch TFT gates of panel matrix (panel matrix) and convert them into digital signals on a line and pass them to the control unit. The digital data generated is then passed to the PC via Ethernet.
H&abyz Co., Ltd
HAD1717MC
In Commercial Distribution

  • 08800070400012 ()


  • Indirect flat panel x-ray detector

ADD - 08800070400005

The ADD is a Flat Panel Digital X-ray Detector which have 425.04 x 425.6mm (HAD1717MCW) or 345.24 x 425.6mm (HAD1417MCW) effective pixel area. The device communicates by the wired Ethernet and wireless Wi-Fi communication feature. The detector should be integrated with a Console PC and a X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic (the Console PC and X-Ray Generator are not provided from H&Abyz). The ADD consists of the following components: Flat Panel Detector, power supply box, switch box, cable, battery, and battery recharger.
H&abyz Co., Ltd
HAD1417MCW
In Commercial Distribution

  • 08800070400005 ()
HAD1417MCW

  • Indirect flat panel x-ray detector

Wireless Digital Flat Panel Detector - 08800061700015

Mars1417V-TSI Wireless Flat Panel Detector with only one package
iRay Korea Limited
Mars1417V-TSI
In Commercial Distribution

  • 08800061700015 ()


  • Indirect flat panel x-ray detector

ScatPad - 00814907020678

SCATPAD STSN 802 Table Skirt Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Dual Level
CARDIO-MEDICAL PRODUCTS, INC.
STSN 802
In Commercial Distribution

  • 00814907020678 ()
STSN 802

  • Radiation shielding panel, portable/mobile

ScatPad - 00814907020661

SCATPAD SJAA 601-XJugular Access / TIPS Custom Shield, Attenuation @90k Vp > 75% (0.125mm), Scatter Radiation Drape, Absorbent, Split Fenestration, Airtex Fabric, Single Level, Tape
CARDIO-MEDICAL PRODUCTS, INC.
SJAA 601-X
In Commercial Distribution

  • 10814907020668 ()
  • 00814907020661 ()
SJAA 601-X

  • Radiation shielding panel, portable/mobile

ScatPad - 00814907020654

SCATPAD SEPA 463-X-AFCath/EP Multi-Purpose Extra Large Specialty Shield, Attenuation @90k Vp > 95% (0.375mm), Scatter Radiation Drape, Absorbent, Airtex Fabric, Scoop and Adjustable Fenestration Tri Level, Tape
CARDIO-MEDICAL PRODUCTS, INC.
SEPA 463-X-AF
In Commercial Distribution

  • 10814907020651 ()
  • 00814907020654 ()
SEPA 463-X-AF

  • Radiation shielding panel, portable/mobile

ScatPad - 00814907020647

SCATPAD SEPA 453-X EP Specialty Shield, Attenuation @90k Vp > 95% (0.375mm), Scatter Radiation Drape, Absorbent, Scoop Fenestration, Tri Level
CARDIO-MEDICAL PRODUCTS, INC.
SEPA 453-X
In Commercial Distribution

  • 10814907020644 ()
  • 00814907020647 ()
SEPA 453-X

  • Radiation shielding panel, portable/mobile

ScatPad - 00814907020630

SCATPAD SMA 123 Multipurpose Shield, Attenuation @90k Vp > 95% (0.375mm), Scatter Radiation Drape, Absorbent, Multipurpose Shield for IR, EP, Cath Lab & OR, Tri Level
CARDIO-MEDICAL PRODUCTS, INC.
SMA 123
In Commercial Distribution

  • 00814907020630 ()
SMA 123

  • Radiation shielding panel, portable/mobile

ScatPad - 00814907020623

SCATPAD SEPA 402-A EP Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Scoop Fenestration Dual Level
CARDIO-MEDICAL PRODUCTS, INC.
SEPA 402-A
In Commercial Distribution

  • 10814907020620 ()
  • 00814907020623 ()
SEPA 402-A

  • Radiation shielding panel, portable/mobile

ScatPad - 00814907020609

SCATPAD SDFA 702 EP Dialysis/DE-Clotting Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Shield Size 5” x 12” Dual Level
CARDIO-MEDICAL PRODUCTS, INC.
SDFA 702
In Commercial Distribution

  • 10814907020606 ()
  • 00814907020609 ()
SDFA 702

  • Radiation shielding panel, portable/mobile

ScatPad - 00814907020593

SCATPAD SDFA 701 EP Dialysis/DE-Clotting Shield, Attenuation @90k Vp > 75% (0.125mm), Scatter Radiation Drape, Absorbent, Shield Size 5” x 12” Single Level
CARDIO-MEDICAL PRODUCTS, INC.
SDFA 701
In Commercial Distribution

  • 10814907020590 ()
  • 00814907020593 ()
SDFA 701

  • Radiation shielding panel, portable/mobile

ScatPad - 00814907020579

SCATPAD SPA 502 Peripheral Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Dual Level
CARDIO-MEDICAL PRODUCTS, INC.
SPA 502
In Commercial Distribution

  • 10814907020576 ()
  • 00814907020579 ()
SPA 502

  • Radiation shielding panel, portable/mobile

ScatPad - 00814907020562

SCATPAD SPA 501 Peripheral Shield, Attenuation @90k Vp > 75% (0.125mm), Scatter Radiation Drape, Absorbent, Single Level
CARDIO-MEDICAL PRODUCTS, INC.
SPA 501
In Commercial Distribution

  • 10814907020569 ()
  • 00814907020562 ()
SPA 501

  • Radiation shielding panel, portable/mobile

ScatPad - 00814907020555

SCATPAD 412 EP Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Rectangular Fenestration Dual Level
CARDIO-MEDICAL PRODUCTS, INC.
SEPA 412
In Commercial Distribution

  • 10814907020552 ()
  • 00814907020555 ()
SEPA 412

  • Radiation shielding panel, portable/mobile

ScatPad - 00814907020548

SCATPAD SEPA 442 EP Multi-Purpose Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Scoop Fenestration Dual Level, Tape
CARDIO-MEDICAL PRODUCTS, INC.
SEPA 442
In Commercial Distribution

  • 10814907020545 ()
  • 00814907020548 ()
SEPA 442

  • Radiation shielding panel, portable/mobile
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