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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 MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901483
In Commercial Distribution

  • 00841549108198 ()


  • Screw endosteal dental implant, one-piece
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901482
In Commercial Distribution

  • 00841549108181 ()


  • Screw endosteal dental implant, one-piece
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901481
In Commercial Distribution

  • 00841549108174 ()


  • Screw endosteal dental implant, one-piece
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901480
In Commercial Distribution

  • 00841549108167 ()


  • Screw endosteal dental implant, one-piece
1mL 25G x 1"
Shina Corporation
1251
In Commercial Distribution

  • 08800117112519 ()
  • 18800117112516 ()
  • 28800117112513 ()


  • Insulin syringe/needle, basic
A non-medicated sterile device in the form of a patch, made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes.
Medique Products
69601
In Commercial Distribution

  • 50347682696011 ()
  • 00347682696016 ()
69601

  • Non-woven gauze pad
MicroIntroducer 3Fr x 7cm ELITE HV
GALT MEDICAL CORP.
CLI-136-00
In Commercial Distribution

  • 20841268108435 ()
  • 10841268108438 ()
  • 00841268108431 ()

  • Catheter Gauge: 3 French
CLI-136-00

  • Haemostasis valve
23G ETW X 7MM PEN NEEDLE US
Becton, Dickinson and Company Inc
4736989
Not in Commercial Distribution

  • 50382904736984 ()
  • 00382904736989 ()

  • Needle Gauge: 23 Gauge
  • Length: 7 Millimeter
47369802

  • Autoinjector needle
.018" (0.46MM) X 35CM ALLEVIO GUIDEWIRE
JET MEDICAL, INC.
JT110183500
Not in Commercial Distribution

  • 50810988020816 ()
  • 00810988020811 ()

  • Length: 35 Centimeter
  • Outer Diameter: .46 Millimeter
  • Outer Diameter: .018 Inch
JT110183500

  • Nasopharyngeal catheter
No Description
XENCO MEDICAL LLC
XM-217-0090
In Commercial Distribution

  • B064XM21700901 ()


  • Bone-screw internal spinal fixation system rod
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