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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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Mg OSTEOCRETE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
10cc
In Commercial Distribution

  • B4474410000BSI0 ()
44-100-00-BSI

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOCRETE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
5cc
In Commercial Distribution

  • B4474405000STR0 ()
44-050-00-STR

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOREVIVE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOREVIVE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
5cc
In Commercial Distribution

  • B4474405000REV0 ()
44-050-00-REV

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOINJECT™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOINJECT™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
5cc
In Commercial Distribution

  • B4474405000INJ0 ()
44-050-00-INJ

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOCRETE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
5cc
In Commercial Distribution

  • B4474405000BSI0 ()
44-050-00-BSI

  • Bone matrix implant, synthetic, non-antimicrobial
A device intended to be used to compress the nose externally, to ensure that airflow is exclusively conducted through the mouth during examinations of the pulmonary function (e.g., spirometry), and/or to stop nosebleeds (epistaxis). It is typically constructed of plastic with rubber or foam tips. This is a single-use device.
POLYTECHNIC RESOURCES INC
N100753S
In Commercial Distribution

  • B446N100753S0 ()
  • B446N100753S1 ()


  • Nose clip, single-use
Intended for use as a Lingual Retainer Wire. Ortho Flex Tech® is best used for lower lingual 3 to 3 retainers and upper lingual 2 to 2 fixed retainers. This 14 Karat White Gold product is etched on one side. This is a nickel free version of Ortho FlexTech
RELIANCE ORTHODONTIC PRODUCTS INC
NFOFT
In Commercial Distribution

  • D798NFOFT0 ()
NFOFT

  • Orthodontic retainer
A device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.
Tenco
Orthodontic Tube
In Commercial Distribution

  • D263021 ()


  • Orthodontic tube
The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic and functions to hold the teeth in their new positions after orthodontic tooth movement is achieved. During this phase of treatment, the fundamental function of the appliance is to maintain tooth position rather than provided continuous force application.
Clearcorrect Operating, LLC
Retainer
In Commercial Distribution

REF04

  • Orthodontic retainer
The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic and functions to hold the teeth in their new positions after orthodontic tooth movement is achieved. During this phase of treatment, the fundamental function of the appliance is to maintain tooth position rather than provided continuous force application.
Clearcorrect Operating, LLC
Retainer
Not in Commercial Distribution

  • D865REF00041 ()
REF-04

  • Orthodontic retainer
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