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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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No Description
JERON ELECTRONIC SYSTEMS, INC.
ProAlert 570
In Commercial Distribution

  • 00860002736006 ()
ProAlert 570

  • Nurse call system
Fukuda Denshi USA, Inc. Spot check Vital Signs Monitor
FUKUDA DENSHI USA, INC.
Fukuda VSM
In Commercial Distribution

  • 00860002604404 ()


  • General-purpose multi-parameter bedside monitor
No Description
Luminance Medical Ventures Incorporated
TN1927D
In Commercial Distribution

  • 00860002593036 ()


  • Red/blue light phototherapy unit
Occlusion Disc, Silicone
GRI MEDICAL PRODUCTS INC
OD-1
In Commercial Distribution

  • 00860002476155 ()
OD-1

  • Gravity enema set
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.
7
In Commercial Distribution

  • 00860002380087 ()


  • Dental milling system, CAD/CAM, laboratory
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.
6.0
In Commercial Distribution

  • 00860002380070 ()


  • Dental milling system, CAD/CAM, laboratory
No Description
Ulab Systems, Inc.
FG0094
Not in Commercial Distribution

  • 00860002380056 ()


  • Dental milling system, CAD/CAM, laboratory
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.
5.9
Not in Commercial Distribution

  • 00860002380049 ()
FG0064

  • Dental milling system, CAD/CAM, laboratory
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 5.8
In Commercial Distribution

  • 00860002380032 ()
FG0064

  • Dental milling system, CAD/CAM, laboratory
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 5.6
In Commercial Distribution

  • 00860002380025 ()
FG0064

  • Dental milling system, CAD/CAM, laboratory
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