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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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Endoscope and Camera Sterilization Tray
PARAGON MEDICAL, INC.
0233-032-302
In Commercial Distribution

  • 00857387006015 ()
0233-032-302

  • Instrument tray, reusable
Advanced Imaging Modality (AIM) Sterilization Tray
PARAGON MEDICAL, INC.
0233-032-301
In Commercial Distribution

  • 00857387006008 ()
0233-032-301

  • Instrument tray, reusable
The Scanmate Flex is a multi-purpose computer based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power. The system consists of three main components: an interface module with integrated probe holder, one or more ultrasonic probes, and the Scanmate software application.
DGH TECHNOLOGY INC.
Scanmate Flex
In Commercial Distribution

  • 00857377006117 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
Sterile, disposable surgical instrument with 8mm cutting tip for large volume debridement of cancellous bone, bio film and marrow.
AVITUS ORTHOPAEDICS, INC.
BH-330
In Commercial Distribution

  • 00857373006142 ()
BH-330

  • Bone graft harvesting filter
  • Neurosurgical curette, single-use
Surgical tray to store the PH11, and other Avitus devices intended for the tray, during sterilization, aseptic presentation, and transportation within the hospital.
AVITUS ORTHOPAEDICS, INC.
ST-01
In Commercial Distribution

  • 00857373006135 ()
ST-01

  • Instrument tray, reusable
Avitus DragonWing Large Volume Autograft Delivery (Ø5.2mm, 120mm system)
AVITUS ORTHOPAEDICS, INC.
AD-5ch-5.2-120
In Commercial Distribution

  • 00857373006128 ()
AD-5ch-5.2-120

  • Bone grafting cannula
Avitus® ArchiMIS Precision Autograft Delivery (Ø4.0mm, 120mm system)
AVITUS ORTHOPAEDICS, INC.
AD-1ch-4.0-120
In Commercial Distribution

  • 00857373006111 ()
AD-1ch-4.0-120

  • Bone grafting cannula
Reusable surgical instrument with 11mm tip for manually cutting a hole into bone allowing access to cancellous bone.
AVITUS ORTHOPAEDICS, INC.
PH11
In Commercial Distribution

  • 00857373006104 ()
PH11

  • Bone awl, reusable
Sterile, disposable surgical instrument with 6mm cutting tip for large volume, cancellous bone and marrow harvesting with marrow separation insert.
AVITUS ORTHOPAEDICS, INC.
BH-220
In Commercial Distribution

  • 00857373006074 ()
BH-220

  • Bone graft harvesting filter
  • Neurosurgical curette, single-use
Disposable surgical instrument with 11mm tip for manually cutting a hole into bone allowing access to cancellous bone.
AVITUS ORTHOPAEDICS, INC.
PC-100
In Commercial Distribution

  • 00857373006067 ()
PC-100

  • Bone awl, single-use
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