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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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Biomet Orthopedics, LLC
904753
In Commercial Distribution

  • 00880304469471 ()

  • 4.5 MM
904753

  • Tendon/ligament bone anchor, non-bioabsorbable
Rectosigmoidoscope with obturator, compatible with Storz Light Source for 20R3 / 9052
Bk Medical ApS
UA0673
In Commercial Distribution

  • 05704916001360 ()


  • Rigid endoscope obturator
Rectosigmoidoscope with obturator, compatible with Welch Allyn Light Source for 20R3 / 9052
Bk Medical ApS
UA0672
In Commercial Distribution

  • 05704916001353 ()


  • Rigid endoscope obturator
Artemis along with the Needle Guide Attachment is used for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Ultrasound, Magnetic Resonance, Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement. The software also provides a virtual grid on the live ultrasound for performing systematic sampling of the target organ. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, reporting, and pathology management. Artemis is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, soft tissue ablations and placement of fiducial markers. Artemis is also intended to be used for patients in active surveillance to keep track of previous procedures information and outcomes.
Eigen Health Services LLC
2.0 HD
In Commercial Distribution

  • 00860009734838 ()


  • Rectal ultrasound navigational image processor
Power muscle stimulator with Electrodes
Emsi
FLEMC0001
In Commercial Distribution

  • 00859718007289 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Transcutaneous electrical stimulation electrode, single-use
ActiSplint with Sensi-Wrap 2"x5yds, Red/Charcoal Gray Rolled Splint, Black Self-Adherent Bandage, 36" ActiSplint, 2"x5 Sensi Wrap; Combo Packs
Dynarex Corporation
3533
In Commercial Distribution

  • 00616784353319 ()
  • 00616784353333 ()


  • Arm splint system, self-moulding
30cm Cannula with Guide
ATRICURE, INC.
CSK-6131
In Commercial Distribution

  • 10840143901607 ()
  • 30840143901670 ()
  • 50840143900110 ()

  • Length: 30 Centimeter
A001311

  • Cardiac radio-frequency ablation system generator
A handheld oscillating positive expiratory pressure device for secretion clearance with the ability to deliver supplemental oxygen when used with compressed oxygen.
D R BURTON HEALTHCARE, LLC
1
In Commercial Distribution

  • 30851232007685 ()
  • 10851232007681 ()
537

  • Incentive spirometer
The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
NEPHROS, INC.
70-0243O
Not in Commercial Distribution

  • 10896241002517 ()
  • 00896241002510 ()
  • 20896241002514 ()


  • Microbial water purification filter, non-sterilizable
The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
NEPHROS, INC.
70-0243O
Not in Commercial Distribution

  • 10896241002500 ()
  • 00896241002503 ()


  • Microbial water purification filter, non-sterilizable
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