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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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Standard Non-Sleeve Adult Anorectal Catheter (with balloon) 6 Channels
H & A Mui Enterprises Inc
CR1-Anorectal-Clin 5
In Commercial Distribution

  • 00678467500878 ()


  • Gastrointestinal motility manometric catheter, non-electronic
Standard Non-Sleeve Adult Oesophageal Catheter 8 Channels
H & A Mui Enterprises Inc
CE1-Oesoph-Clin 5
In Commercial Distribution

  • 00678467500533 ()


  • Gastrointestinal motility manometric catheter, non-electronic
Clear TPE Beaded Balloon 5 pack
H & A Mui Enterprises Inc
CBS6TB(5)
In Commercial Distribution

  • 00678467005533 ()


  • Gastrointestinal motility manometric catheter, non-electronic
Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
In Commercial Distribution

  • 00868201000171 ()
131133-05-S

  • Bone matrix implant, synthetic, non-antimicrobial
Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
Not in Commercial Distribution

  • 00868201000140 ()


  • Bone matrix implant, synthetic, non-antimicrobial
Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
Not in Commercial Distribution

  • 00868201000119 ()
131133-05

  • Bone matrix implant, synthetic, non-antimicrobial
Xoran Workstation is an image processing and viewing software for use with compatible radiographic data. The workstation software provides tools for image processing, viewing, interpretation, annotation, clinical review, analysis, distribution, archival, printing, and administrative reporting by healthcare professionals.
XORAN TECHNOLOGIES LLC
v.5
In Commercial Distribution

  • 00860008443717 ()


  • Diagnostic x-ray digital imaging system workstation application software
Vac Abdominal Dressing Featuring Sensatrac Technology
KCI USA, INC.
M8275080/5
In Commercial Distribution

  • 00878237001325 ()


  • Negative-pressure wound therapy open-abdomen dressing
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers
Ulab Systems, Inc.
Version 5
Not in Commercial Distribution

  • 00860002380001 ()
FG0064

  • Dental milling system, CAD/CAM, laboratory
MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain, MRCAT Head &Neck)
Philips Medical Systems Nederland B.V.
RTgo 5
In Commercial Distribution

  • 00884838122123 ()
781439

  • MRI system application software
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