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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INTERVENTIONAL PLATFORM X-RAY BARRIER W/ SEAT
AADCO MEDICAL, INC.
S-691
In Commercial Distribution

  • 00840348509496 ()
S-691

  • Radiation shielding panel, portable/mobile
RAYSHIELD INTERVENTIONAL PLATFORM X-RAY BARRIER
AADCO MEDICAL, INC.
S-690
In Commercial Distribution

  • 00840348509489 ()
S-690

  • Radiation shielding panel, portable/mobile
UPRIGHT INTERVENTIONAL BARRIER MRI-SAFE
AADCO MEDICAL, INC.
S-620NF
In Commercial Distribution

  • 00840348509366 ()
S-620NF

  • Radiation shielding panel, portable/mobile
Upright Interventional X-ray Barrier 0.5mm
AADCO MEDICAL, INC.
S-620
In Commercial Distribution

  • 00840348509359 ()
S-620

  • Radiation shielding panel, portable/mobile
ADJUST A HEIGHT OVER TABLE CAMERA MOUNT
AADCO MEDICAL, INC.
S-616
In Commercial Distribution

  • 00840348509342 ()
S-616

  • Radiation shielding panel, portable/mobile
BARRIER ACCES. RAIL 10MM
AADCO MEDICAL, INC.
S-610B
In Commercial Distribution

  • 00840348509335 ()
S-610B

  • Radiation shielding panel, portable/mobile
BARRIER ACCESSORY RAIL 8MMX25MM
AADCO MEDICAL, INC.
S-610A
In Commercial Distribution

  • 00840348509328 ()
S-610A

  • Radiation shielding panel, portable/mobile
ADJUST-A-HEIGHT BARRIER
AADCO MEDICAL, INC.
S-610
In Commercial Distribution

  • 00840348509311 ()
S-610

  • Radiation shielding panel, portable/mobile
MOBILE BARRIER .5MM 30X60 VIEWING PANEL
AADCO MEDICAL, INC.
S-608
In Commercial Distribution

  • 00840348509304 ()
S-608

  • Radiation shielding panel, portable/mobile
MRI-SAFE REGULAR WIDE MOBILE BARRIER 0.5MM
AADCO MEDICAL, INC.
S-607NF
In Commercial Distribution

  • 00840348509298 ()
S-607NF

  • Radiation shielding panel, portable/mobile
REG WIDE MOBILE BARRIER .5MM
AADCO MEDICAL, INC.
S-607
In Commercial Distribution

  • 00840348509281 ()
S-607

  • Radiation shielding panel, portable/mobile
MRI-SAFE JUMBO MOBILE BARRIER 0.5MM
AADCO MEDICAL, INC.
S-606NF
In Commercial Distribution

  • 00840348509274 ()
S-606NF

  • Radiation shielding panel, portable/mobile
No Description
Corindus, Inc.
101
In Commercial Distribution

  • 00816280021013 ()
101

  • Radiation shielding panel, portable/mobile
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 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 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 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 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 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 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 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 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 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 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 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
SCATPAD 403-CTRSCP EP Shield, Attenuation @90k Vp > 95% (0.375mm), Scatter Radiation Drape, Absorbent, Center Scoop Fenestration Tri Level
CARDIO-MEDICAL PRODUCTS, INC.
SEPA 403-CTRSCP
In Commercial Distribution

  • 10814907020507 ()
  • 00814907020500 ()
SEPA 403-CTRSCP

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

  • 10814907020460 ()
  • 00814907020463 ()
SEPA 402-DT

  • Radiation shielding panel, portable/mobile
SCATPAD SEPA 401 EP SHIELD, ATTENUATION @90kVp >75% (0.125mm), SCATTER RADIATION DRAPE
CARDIO-MEDICAL PRODUCTS, INC.
SAPA 401
In Commercial Distribution

  • 00814907020456 ()
  • 10814907020453 ()
SAPA 401

  • Radiation shielding panel, portable/mobile
SCATPAD SAFA 302 Angiography Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Circular Fenestration Dual Level
CARDIO-MEDICAL PRODUCTS, INC.
SAFA 302
In Commercial Distribution

  • 10814907020439 ()
  • 00814907020432 ()
SAFA 302

  • Radiation shielding panel, portable/mobile
SCATPAD SAFA 301 Angiography Shield, Attenuation @90k Vp > 75% (0.125mm), Scatter Radiation Drape, Absorbent, Circular Fenestration Single Level
CARDIO-MEDICAL PRODUCTS, INC.
SAFA 301
In Commercial Distribution

  • 10814907020422 ()
  • 00814907020425 ()
SAFA 301

  • Radiation shielding panel, portable/mobile
SCATPAD SMA 102 Multipurpose Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Multipurpose Shield for IR, EP, Cath Lab & OR, Dual Level
CARDIO-MEDICAL PRODUCTS, INC.
SMA 102
In Commercial Distribution

  • 10814907020347 ()
  • 00814907020340 ()
SMA 102

  • Radiation shielding panel, portable/mobile
XRpad2 is a lightweight, cassette-sized flat panel detector for digital radiography.
VAREX IMAGING CORPORATION
3025 HWC-M
In Commercial Distribution

  • 00810751030078 ()


  • Indirect flat panel x-ray detector
The Varex Imaging XRpad 4343 F MED is a lightweight, cassette-sized flat panel detector for digital radiography. It fits into a conventional table or wall-stand bucky, just like a film-screen cassette. Featuring a 18.7 million pixel image matrix, a best-in-class 100 um pixel pitch, and a direct deposited CsI scintillator, the XRpad 4343 F MED provides exceptional image quality with a true 43 cm × 43 cm imaging area. A robust and lightweight aluminum frame with carbon-fiber entrance window allows for easier placement and cleaning. Automatic Exposure Detection simplifies integration.
VAREX IMAGING WEST, LLC
4343 F MED
In Commercial Distribution


  • Width: 460 Millimeter
  • Weight: 4.1 Kilogram
  • Depth: 15 Millimeter
  • Length: 460 Millimeter
95510935-02

  • Indirect flat panel x-ray detector
XRpad2 4336 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 um pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 4336 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 4336 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 8 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.
VAREX IMAGING WEST, LLC
4336 HWC-M
In Commercial Distribution


  • Depth: 15.5 Millimeter
  • Length: 460 Millimeter
  • Width: 384 Millimeter
  • Weight: 3.2 Kilogram
95510981

  • Indirect flat panel x-ray detector
XRpad2 3025 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 um pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 3025 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 3025 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 10 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.
VAREX IMAGING WEST, LLC
3025 HWC-M
In Commercial Distribution


  • Depth: 15.5 Millimeter
  • Length: 332 Millimeter
  • Width: 282 Millimeter
  • Weight: 1.8 Kilogram
95510991

  • Indirect flat panel x-ray detector
XRpad2 4343 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 um pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 4343 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 4343 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 8 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.
VAREX IMAGING WEST, LLC
4343 HWC-M
In Commercial Distribution

  • 00810751030009 ()

  • Depth: 15.5 Millimeter
  • Length: 460 Millimeter
  • Width: 460 Millimeter
  • Weight: 3.8 Kilogram
95510607

  • Indirect flat panel x-ray detector
Mobile Radiation Barrier 30x60 window 2mmPbeq
Techno-Aide, Inc.
MB3060G20
In Commercial Distribution

  • G242MB3060G2090 ()
  • G242MB3060G209 ()
MB3060G20

  • Radiation shielding panel, portable/mobile
Mobile Radiation Barrier 24x30 window 2mmPbeq
Techno-Aide, Inc.
MB2430G20
In Commercial Distribution

  • G242MB2430G2090 ()
  • G242MB2430G209 ()
MB2430G20

  • Radiation shielding panel, portable/mobile
DELUXE SHIELD - 30 x 42 - 0.50mm Lead Equivalence -REGULAR LEADED PROTECTIVE MEDIA - T Base
Techno-Aide, Inc.
LPS-T3042S
In Commercial Distribution

  • G242LPST3042S90 ()
  • G242LPST3042S9 ()
LPS-T3042S

  • Radiation shielding panel, portable/mobile
DELUXE SHIELD - 30 x 36 - 0.50mm Lead Equivalence -REGULAR LEADED PROTECTIVE MEDIA - T Base
Techno-Aide, Inc.
LPS-T3036S
In Commercial Distribution

  • G242LPST3036S90 ()
  • G242LPST3036S9 ()
LPS-T3036S

  • Radiation shielding panel, portable/mobile
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