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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ZENITH™ ROTH CMP LWR LT 2ND BIC W/HK 022, -22°T, 0°A Zenith™ Series Composite [CM] aesthetic brackets are precision designed and manufactured so that no special treatment mechanics or bonding procedures are necessary. All of the same clinical techniques routinely used with metal brackets are applicable with Zenith™. Zenith™ brackets are designed with all the features needed to achieve contemporary treatment objectives including rounded contours for comfort and reduced friction, sweeping tie wing undercuts, notched bases for mechanical bonds, plus many more.
G & H Wire Company, Inc.
RCMLL523-V
In Commercial Distribution

  • 10190886009727 ()
  • 00190886009720 ()


  • Orthodontic bracket, plastic, single-use
ZENITH™ ROTH CMP LWR LT 2ND BIC W/HK 018, -22°T, 0°A Zenith™ Series Composite [CM] aesthetic brackets are precision designed and manufactured so that no special treatment mechanics or bonding procedures are necessary. All of the same clinical techniques routinely used with metal brackets are applicable with Zenith™. Zenith™ brackets are designed with all the features needed to achieve contemporary treatment objectives including rounded contours for comfort and reduced friction, sweeping tie wing undercuts, notched bases for mechanical bonds, plus many more.
G & H Wire Company, Inc.
RCMLL519-V
In Commercial Distribution

  • 10190886009710 ()
  • 00190886009713 ()


  • Orthodontic bracket, plastic, single-use
ZENITH™ ROTH CMP LWR LT 1ST BIC W/HK 022, -17°T, 0°A Zenith™ Series Composite [CM] aesthetic brackets are precision designed and manufactured so that no special treatment mechanics or bonding procedures are necessary. All of the same clinical techniques routinely used with metal brackets are applicable with Zenith™. Zenith™ brackets are designed with all the features needed to achieve contemporary treatment objectives including rounded contours for comfort and reduced friction, sweeping tie wing undercuts, notched bases for mechanical bonds, plus many more.
G & H Wire Company, Inc.
RCMLL423-V
In Commercial Distribution

  • 10190886009703 ()
  • 00190886009706 ()


  • Orthodontic bracket, plastic, single-use
ZENITH™ ROTH CMP LWR LT 1ST BIC W/HK 018, -17°T, 0°A Zenith™ Series Composite [CM] aesthetic brackets are precision designed and manufactured so that no special treatment mechanics or bonding procedures are necessary. All of the same clinical techniques routinely used with metal brackets are applicable with Zenith™. Zenith™ brackets are designed with all the features needed to achieve contemporary treatment objectives including rounded contours for comfort and reduced friction, sweeping tie wing undercuts, notched bases for mechanical bonds, plus many more.
G & H Wire Company, Inc.
RCMLL419-V
In Commercial Distribution

  • 10190886009697 ()
  • 00190886009690 ()


  • Orthodontic bracket, plastic, single-use
ZENITH™ ROTH CMP LWR LT CUSPID W/HK 022, -11°T, 5°A Zenith™ Series Composite [CM] aesthetic brackets are precision designed and manufactured so that no special treatment mechanics or bonding procedures are necessary. All of the same clinical techniques routinely used with metal brackets are applicable with Zenith™. Zenith™ brackets are designed with all the features needed to achieve contemporary treatment objectives including rounded contours for comfort and reduced friction, sweeping tie wing undercuts, notched bases for mechanical bonds, plus many more.
G & H Wire Company, Inc.
RCMLL323-V
In Commercial Distribution

  • 10190886009680 ()
  • 00190886009683 ()


  • Orthodontic bracket, plastic, single-use
ZENITH™ ROTH CMP LWR LT CUSPID W/HK 018, -11°T, 5°A Zenith™ Series Composite [CM] aesthetic brackets are precision designed and manufactured so that no special treatment mechanics or bonding procedures are necessary. All of the same clinical techniques routinely used with metal brackets are applicable with Zenith™. Zenith™ brackets are designed with all the features needed to achieve contemporary treatment objectives including rounded contours for comfort and reduced friction, sweeping tie wing undercuts, notched bases for mechanical bonds, plus many more.
G & H Wire Company, Inc.
RCMLL319-V
In Commercial Distribution

  • 10190886009666 ()
  • 00190886009669 ()


  • Orthodontic bracket, plastic, single-use
The CPI RAD VISION digital imaging system is a full-featured radiographic imaging system that is designed to capture digital radiographic X-ray images in hospitals and clinics. Generator controls for setting exposure factors and techniques are included along with the image acquisition functions. Images are automatically pre-processed during acquisition, and further image processing may be applied after the images have been acquired or stored. This allows the image(s) to be enhanced to improve the visualization of anatomical details. Images may be stored on the built-in hard disk, on optical disc (CD/DVD-R/RW), or on a DICOM 3.0 compliant network storage device. This is a non-invasive device, designed to image the major systems of the body: Skull, neck, chest, abdomen, pelvis, and extremities. It is not intended for mammographic, fluoroscopic, and / or angiographic applications. The CPI RAD VISION digital imaging system is intended for use with CPI CMP 200 DR or Indico 100 X-ray generators.
Communications & Power Industries Canada Inc
VZW2944M9
In Commercial Distribution

  • 00885310000021 ()


  • Stationary basic diagnostic x-ray system, digital
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