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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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CERVICAL PLATE L:27mm
SPINEWAY
2
In Commercial Distribution

  • 03663422040305 ()

  • Length: 27 Millimeter
BM2P27

  • Spinal fixation plate, non-bioabsorbable
CERVICAL PLATE L:24mm
SPINEWAY
2
In Commercial Distribution

  • 03663422040299 ()

  • Length: 24 Millimeter
BM2P24

  • Spinal fixation plate, non-bioabsorbable
The AHI System is an adjunctive monitoring method to enable identification of patients who are showing signs of hemodynamic instability or are likely to experience a future episode of hemodynamic instability, and to allow clinicians an opportunity to increase vigilance.
Fifth Eye, Inc.
2
In Commercial Distribution

  • B823AHIV200 ()


  • Clinical management support software
No Description
EOS IMAGING
2
In Commercial Distribution

  • 03663999000139 ()


  • Diagnostic x-ray system chair
Rasp 10S, cervical
SPINEWAY
2
Not in Commercial Distribution

  • 03663422606488 ()

  • S
  • Height: 10 Millimeter
530RC10S2

  • Orthopaedic surgical procedure kit, non-medicated, reusable
The PreOp Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study. The import process allows the user to select a DICOM CT scan series from any location that the user's computer sees as an available file source. 3D digital representations of various implant models are available in the planning software. Pre-Op Shoulder allows the user to digitally perform the surgical planning by showing a representation of the patient's shoulder anatomy as a 3D model and allows the surgeon to place the implant in the patient's anatomy. The software allows the surgeon to generate a report, detailing the output of the planning activity. Experience in usage and a clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes. Instructions for use can be found at the following location: https://portal.si.genesisplanningsoftware.com/
Genesis Software Innovations LLC
2
In Commercial Distribution

  • B973PREOPSHOULDER0 ()


  • Image segmentation application software
Fertility lubricant, 40 gram tube with 10 applicators
FAIRHAVEN HEALTH, L.L.C.
2
In Commercial Distribution

  • 00896593002497 ()


  • Sexual lubricant
Tamper-Evident Catheter Access Cover
PICCGUARD, LLC
2
In Commercial Distribution

  • B38320517205182 ()


  • Intravenous catheter injection port guard
AMSure® Enteral Administration Kit CONTENTS: Enteral Feeding 1200mL Bag Gravity Set with ENFit Connector, ENFit Transition Connector
AMSINO INTERNATIONAL, INC.
2
In Commercial Distribution

  • 40704411006566 ()
  • 10704411006565 ()
ENF1203K

  • Enteral feeding kit, adult/paediatric, non-sterile
AMSure® Enteral Administration Kit FOR USE WITH THE SENTINEL® ENTERAL FEEDING PUMP CONTENTS: Enteral Feeding 1200mL Bag Pump Set with ENFit Connector, ENFit Transition Connector
AMSINO INTERNATIONAL, INC.
2
In Commercial Distribution

  • 40704411006559 ()
  • 10704411006558 ()
ENF1200K

  • Enteral feeding kit, adult/paediatric, non-sterile
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