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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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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.
8
In Commercial Distribution

  • 00860461001769 ()
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 2.2
Not in Commercial Distribution

  • 00860461001707 ()
FG0064

  • Dental milling system, CAD/CAM, laboratory
The C-7000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by chiropractors. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care, similar to a common thermometer
TITRONICS RESEARCH & DEVELOPMENT COMPANY
Tytron C-7000
In Commercial Distribution

  • 00860447001714 ()


  • Thermographic camera
The C-5000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by chiropractors. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care, similar to a common thermometer
TITRONICS RESEARCH & DEVELOPMENT COMPANY
Tytron C-5000
Not in Commercial Distribution

  • 00860447001707 ()


  • Thermographic camera
Pneumatic plethysmograph.
ACI MEDICAL LLC
APG-1000
In Commercial Distribution

  • 00860446000312 ()
APG-1000

  • Limb plethysmograph
The Epinephrine Convenience Kit contains a vial of Epinephrine 1mg/mL (1:1000) and two (2) Certa Dose Epinephrine Syringe Devices that are modifications of an existing and commonly used syringe device. The Certa Dose Epinephrine Syringe Device started as an unlabeled off the shelf 3/10 mL syringe that has been modified to use mL graduation marks with color zones that align with color zones that correspond to pediatric weight ranges that can be used as a secondary confirmation that measured volumes are within ranges that are common for a patient’s weight. The Kit is intended for use in clinical and emergency medical settings to assist healthcare professionals and emergency medical personnel in measuring a desired volume of epinephrine for delivery to pediatric patients.
CERTA DOSE, INC.
1
In Commercial Distribution

  • 00860425001606 ()
  • 00860425001613 ()
  • 10860425001603 ()

  • Total Volume: .3 Milliliter
  • Length: .5 Inch
  • Needle Gauge: 29 Gauge
CD-EPI-001

  • General-purpose syringe/needle
No Description
JOINT RESTORATION FOUNDATION INC
1
In Commercial Distribution

  • 00860424000297 ()
PSP-111

  • Tendon graft
No Description
JOINT RESTORATION FOUNDATION INC
1
In Commercial Distribution

  • 00860424000280 ()
PSP-091

  • Tendon graft
No Description
JOINT RESTORATION FOUNDATION INC
1
In Commercial Distribution

  • 00860424000273 ()
SPQ-001

  • Tendon graft
No Description
JOINT RESTORATION FOUNDATION INC
1
In Commercial Distribution

  • 00860424000266 ()
PSA-101

  • Tendon graft
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