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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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MedentiGuide Inner sleeve
MEDENTiKA GmbH
0-32-14
In Commercial Distribution

  • 04251574801449 ()
  • EMKA032149 ()

  • compatible with Quattrocone / Quattrocone30
0-32-14

  • Surgical drill guide, single-use
MedentiGuide Inner sleeve
MEDENTiKA GmbH
0-32-13
In Commercial Distribution

  • 04251574801432 ()
  • EMKA032139 ()

  • compatible with Quattrocone / Quattrocone30
0-32-13

  • Surgical drill guide, single-use
VenaCure OPS 55cm EVLT Fiber
ANGIODYNAMICS, INC.
EVLT55OPSFO
In Commercial Distribution

  • 15051684020848 ()
  • H787EVLT55OPSFO0 ()

  • Length: 2500 Centimeter


  • Varicose vein lasing procedure kit
Persyst ESI powered by Epilog provides Electrical Source Imaging as a service to a clinical user. The clinical user does not interact directly with the device. In the Persyst ESI powered by Epilog service, the device is used by Epilog operators to generate a report. Persyst ESI powered by Epilog is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Clouds of Care
v2
In Commercial Distribution



  • Bioelectrical signal analysis software
PreOp is active medical device software (MSDW) intended for use by a trained Epilog EEG technologist / Operator in combination with Persyst EEG Review and Analysis Software on both adult and pediatric subjects at least 3 years of age for 3D visualization of the human brain function recorded with EEG and using a patient-specific MR image.
Clouds of Care
v2
In Commercial Distribution



  • Bioelectrical signal analysis software
The Cefaly® Prevent device is indicated for the prophylactic treatment of episodic migraine in adults.
Cefaly Technology SPRL
Prevent
In Commercial Distribution

10230

  • Craniofacial analgesia electrical stimulator
PNEUMOSTOP® PLUS DEVICE
LSI Solutions, Inc.
110230
In Commercial Distribution

  • 10850012846014 ()
  • 00850012846017 ()
  • 40850012846015 ()
  • 00850200006759 ()
110230

  • Laparoscopic hysterectomy vaginal occluder
PNEUMOSTOP® DEVICE
LSI Solutions, Inc.
110200
In Commercial Distribution

  • 10850012846007 ()
  • 00850012846000 ()
  • 40850012846008 ()
  • 00850200006742 ()
110200

  • Laparoscopic hysterectomy vaginal occluder
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.3.0
In Commercial Distribution



  • MRI image interpretive software
The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The 45 mL FIBRINET® System is available as a single pack (item number 510359) or as a multipack of 5 individually packaged kits (item number 510359-5). The 45 mL FIBRINET® System contains 5 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 1 PRFM tube containing calcium chloride solution with red stopper, two 30 mL membrane vials with closure containing calcium chloride solution, 1 latex free disposable tourniquet, 2 BD Vacutainer® Luer-Lok™ access devices, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, 2 BD Vacutainer® Blood transfer devices, and 1 vial adapter.
ROYAL BIOLOGICS INC.
PFRMK
In Commercial Distribution


  • Total Volume: 45 Milliliter
510359

  • Haematological concentrate system preparation kit, platelet concentration
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