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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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TISSUE EXPANDER, TEARDROP, ENHANCED TEXTURED SURFACE, 2-STAGE, TANGENT LEFT EXIT
PMT CORPORATION
3612ES-22-2-TL
In Commercial Distribution

  • 00650551137665 ()

  • Projection 8.5 Centimeter
  • Total Volume: 500 Centiliter
  • Length: 13 Centimeter
  • Width: 10 Centimeter
3612ES-22-2-TL

  • Skin-port tissue expander
The Test of Variables of Attention (T.O.V.A.) software is a computerized assessment of attention and inhibitory control that runs on most Windows and Mac-based computers. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Software
In Commercial Distribution

  • 00862290000326 ()


  • Cognitive assessment software
Advanced Wound Care Product, single pouched, 5x5cm
Sweetbio, Inc.
APIS-50x50-2
In Commercial Distribution

  • 00861876000385 ()

  • Length: 5 Centimeter
  • Width: 5 Centimeter
  • Height: 0.03 Centimeter
APIS-50x50-2

  • Animal-derived wound matrix dressing
Advanced Wound Care Product, double pouched, 5x5cm
Sweetbio, Inc.
APIS-50x50-1
In Commercial Distribution

  • 00861876000354 ()

  • Length: 5 Centimeter
  • Width: 5 Centimeter
  • Height: 0.03 Centimeter
APIS-50x50-1

  • Animal-derived wound matrix dressing
Advanced Wound Care Product, double pouched, 16x16mm
Sweetbio, Inc.
APIS-16x16-1
In Commercial Distribution

  • 00861876000316 ()

  • Length: 16 Millimeter
  • Width: 16 Millimeter
  • Height: 0.3 Millimeter
APIS-16x16-1

  • Animal-derived wound matrix dressing
Corplex P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
4 cc
In Commercial Distribution

  • 00860471002572 ()
CP-0040

  • Animal-derived wound matrix dressing
Corplex P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
2 cc
In Commercial Distribution

  • 00860471002565 ()
CP0020

  • Animal-derived wound matrix dressing
Corplex P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
1 cc
In Commercial Distribution

  • 00860471002558 ()
CP-0010

  • Animal-derived wound matrix dressing
The uLab Systems Reva Disc is a non-sterile sheet of thermoplastic intended to be used by a dental practitioner to fabricate polymer orthodontic and dental appliances. The sheets of material are heated by the dental practitioner in an office setting and then vacuum-formed over a dental impression of the patient’s teeth. Once formed, the appliance is then trimmed to fit the patient.
Ulab Systems, Inc.
FG0010
In Commercial Distribution

  • 00860461001790 ()


  • Orthodontic progressive aligner
The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Kit
In Commercial Distribution

  • 00862290000333 ()


  • Cognitive assessment software
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