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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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The DigitalDiagnost is a high-end digital radiography system, that includes - Accessory-lead apron for Vertical stand; - Additional SkyPlate charger; - Adjustable Straps for Patient Support; - Compression Belt (singles. pull); - Detector Holder for Patient Bed; - Hand grips (Pair of); - Handle for Skyplate Large; - Infusion bottle holder; - Mobile Detector Holder; - Paper roll holder; - Patient Support for Stitching; - Portable Panel Protector; - Remote control holder; - Set of 50 Hygienic Bags large; - Set of 50 Hygienic Bags small; - Side Bar; - Stretch Grip for VS/VM Stand; - Table top support
Philips Medical Systems DMC GmbH
712031
In Commercial Distribution

  • 00884838065321 ()
712031

  • Stationary basic diagnostic x-ray system, digital
The DigitalDiagnost C90 is a high-end digital radiography system, that inlcudes - Adjustable Straps for Patient Support; - Battery for SkyPlate E; - Compression Belt (singles. pull); - Hand grips (Pair of); - Infusion bottle holder; - Lateral cassette holder; - Mobile Detector Holder; - Paper roll holder; - Parking frame for accessories; - Patient Support for Stitching; - Remote control holder; - Side Bar; - Stretch Grip for VS/VM Stand; - Table top support
Philips Medical Systems DMC GmbH
712035
In Commercial Distribution

  • 00884838090705 ()


  • Stationary basic diagnostic x-ray system, digital
The DigitalDiagnost C90 is a high-end digital radiography system, that inlcudes - Adjustable Straps for Patient Support; - Battery for SkyPlate E; - Compression Belt (singles. pull); - Hand grips (Pair of); - Infusion bottle holder; - Lateral cassette holder; - Mobile Detector Holder; - Paper roll holder; - Parking frame for accessories; - Patient Support for Stitching; - Remote control holder; - Side Bar; - Stretch Grip for VS/VM Stand; - Table top support
Philips Medical Systems DMC GmbH
712034
In Commercial Distribution

  • 00884838090699 ()


  • Stationary basic diagnostic x-ray system, digital
The DigitalDiagnost is a high-end digital radiography system, that includes - Accessory-lead apron for Vertical stand; - Additional SkyPlate charger; - Adjustable Straps for Patient Support; - Compression Belt (singles. pull); - Detector Holder for Patient Bed; - Hand grips (Pair of); - Handle for Skyplate Large; - Infusion bottle holder; - Mobile Detector Holder; - Paper roll holder; - Patient Support for Stitching; - Portable Panel Protector; - Remote control holder; - Set of 50 Hygienic Bags large; - Set of 50 Hygienic Bags small; - Side Bar; - Stretch Grip for VS/VM Stand; - Table top support
Philips Medical Systems DMC GmbH
712033
In Commercial Distribution

  • 00884838074521 ()
712033

  • Stationary basic diagnostic x-ray system, digital
The DigitalDiagnost is a high-end digital radiography system, that includes - Accessory-lead apron for Vertical stand; - Additional SkyPlate charger; - Adjustable Straps for Patient Support; - Compression Belt (singles. pull); - Detector Holder for Patient Bed; - Hand grips (Pair of); - Handle for Skyplate Large; - Infusion bottle holder; - Mobile Detector Holder; - Paper roll holder; - Patient Support for Stitching; - Portable Panel Protector; - Remote control holder; - Set of 50 Hygienic Bags large; - Set of 50 Hygienic Bags small; - Side Bar; - Stretch Grip for VS/VM Stand; - Table top support
Philips Medical Systems DMC GmbH
712032
In Commercial Distribution

  • 00884838074514 ()
712032

  • Stationary basic diagnostic x-ray system, digital
The Halifax Imaging Kit is part of the SR Suite product line, provides an alternative path to creating an SR Suite. The Halifax Imaging Kit is comprised of FDA cleared or certified X-Ray components integrated into an existing digital radiography room already containing an FDA cleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kit and the existing DR system are synchronized by replacing the trigger switches of the two systems with the Halifax Synchronization Switch. The Halifax Synchronization Switch ensures the two X-Ray imaging systems fire simultaneously, providing a pair of X-Ray images from two different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA) or stereo orthopaedic radiography (SOR). RSA is a stereo x-ray technique that enables measurements more accurate and precise than single plane radiography based on phantom studies. The increased level of precision enables measurement of implant stability.
Halifax Biomedical Incorporated
1
In Commercial Distribution

  • 00628451892021 ()
P008943

  • Stationary basic diagnostic x-ray system, digital
The I-Q View is a software package to be used with FDA cleared solid-state imaging receptors. It functions as a diagnostic x-ray image acquisition platform and allows these images to be transferred to hard copy, softcopy, and archive devices via DICOM protocol.
First Source, Inc.
V5
In Commercial Distribution

  • G221200CA3080 ()
200-CA-308

  • Radiology DICOM image processing application software
The G5 Single Light Camera with Single Flat Panel Monitor Single Cardanic is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167257 ()
LGH38N

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
The G5 Single Light Camera with ConnectPoint Express, Single Flat Panel Monitor is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167165 ()
LGH14NCP

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The G5 Dual Variable No Camera Single Flat Panel Monitor with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167011 ()
LG41N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
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