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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 titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B-BOP plates. They are available in different diameters and sizes. They exist in different colors for size identification. The unthreaded part provides the system with the mechanism for the bone to slide along this unthreaded body. The design of the thread allows the snap-off screw to be self tapping so that no pre-tap is required when implanting the device .The distal end of the snap-off screw has a smooth tip to protect tissues.
NEWDEAL
117120SND
In Commercial Distribution

  • 10381780047834 ()
  • M248117120SND1 ()

  • 3.0mm diam. x 20mm length
117120SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B-BOP plates. They are available in different diameters and sizes. They exist in different colors for size identification. The unthreaded part provides the system with the mechanism for the bone to slide along this unthreaded body. The design of the thread allows the snap-off screw to be self tapping so that no pre-tap is required when implanting the device .The distal end of the snap-off screw has a smooth tip to protect tissues.
NEWDEAL
117116SND
In Commercial Distribution

  • 10381780047803 ()
  • M248117116SND1 ()

  • 3.0mm diam. x 16mm length
117116SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B-BOP plates. They are available in different diameters and sizes. They exist in different colors for size identification. The unthreaded part provides the system with the mechanism for the bone to slide along this unthreaded body. The design of the thread allows the snap-off screw to be self tapping so that no pre-tap is required when implanting the device .The distal end of the snap-off screw has a smooth tip to protect tissues.
NEWDEAL
117114SND
In Commercial Distribution

  • 10381780047780 ()
  • M248117114SND1 ()

  • 3.0mm diam. x 14mm length
117114SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The Capture High-Torque Screw System consists of various sizes of cannulated screws. The screws are machined, metallic screws with a cannulation that are self-drilling and self-tapping. Each type is offered in a variety of diameters and lengths and is manufactured from stainless steel and titanium. The system is intended for fixation of fractures in long bones, fixation of small bones, arthrodesis of the foot, wrist and elbow, and small and long bone osteotomies. This particular system consists of 7.0mm screws. Instruments are provided to assist with the implants.
Ascension Orthopedics, Inc.
HITORQ7IMP
Not in Commercial Distribution

  • M268HITORQ7IMP1 ()
  • 10381780064558 ()
HITORQ7IMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture High-Torque Screw System consists of various sizes of cannulated screws. The screws are machined, metallic screws with a cannulation that are self-drilling and self-tapping. Each type is offered in a variety of diameters and lengths and is manufactured from stainless steel and titanium. The system is intended for fixation of fractures in long bones, fixation of small bones, arthrodesis of the foot, wrist and elbow, and small and long bone osteotomies. This particular system consists of 4.0mm and 5.0mm screws. Instruments are provided to assist with the implants.
Ascension Orthopedics, Inc.
HITORQ45IMP
Not in Commercial Distribution

  • M268HITORQ45IMP1 ()
  • 10381780064541 ()
HITORQ45IMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture High-Torque Screw System consists of various sizes of cannulated screws. The screws are machined, metallic screws with a cannulation that are self-drilling and self-tapping. Each type is offered in a variety of diameters and lengths and is manufactured from stainless steel and titanium. The system is intended for fixation of fractures in long bones, fixation of small bones, arthrodesis of the foot, wrist and elbow, and small and long bone osteotomies. This particular system consists of 2.0mm and 3.0mm screws. Instruments are provided to assist with the implants.
Ascension Orthopedics, Inc.
HITORQ23IMP
Not in Commercial Distribution

  • M268HITORQ23IMP1 ()
  • 10381780064534 ()
HITORQ23IMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Screw System is comprised of headless screws used for bone fixation of the hand and foot, following trauma or osteotomy. All screws are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The headless screw is a cannulated, dual-thread headless bone screw which is offered in 2.5 and 3.0mm diameters with lengths of 10 – 34mm. The quick snap screw is a snap-off solid screw which is offered in 2.0mm and 2.7mm diameters with lengths of 8-22mm. The system includes instruments to facilitate the placement of the screws.
Ascension Orthopedics, Inc.
CAPHLESSIMP
Not in Commercial Distribution

  • M268CAPHLESSIMP1 ()
  • 10381780064510 ()
CAPHLESSIMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
AMERICAN DENTAL PRODUCTS INC
10 ml
Not in Commercial Distribution

  • 00865849000228 ()

  • Total Volume: 10 Milliliter
9515140

  • Dental coating, tooth-desensitizing
A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
AMERICAN DENTAL PRODUCTS INC
10 ml
Not in Commercial Distribution

  • 00865849000242 ()

  • Total Volume: 10 Milliliter
9515140

  • Dental coating, tooth-desensitizing
A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
AMERICAN DENTAL PRODUCTS INC
G6
Not in Commercial Distribution

  • 00865849000211 ()

  • Total Volume: 5 Milliliter


  • Dental coating, tooth-desensitizing
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