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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 and HALLU-S 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
117010ND
In Commercial Distribution

  • M248117010ND1 ()
  • 10381780047476 ()

  • 2.7mm diam. x 10mm length
117010ND

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Integra Ti6 Internal Fixation System is comprised of Headless screws used for bone fixation of the hand and foot following trauma or osteotomy. The titanium headless screw is a cannulated dual-thread, headless bone screw which is offered in 2.5 and 3.0mm diameters with lengths of 10 to 24mm. The titanium quick snap is a snap-off solid core screw which is offered in 2.0mm and 2.7mm diameters with lengths of 8 to 22mm.The system includes titanium and stainless steel instruments to facilitate the placement of the screws.
Ascension Orthopedics, Inc.
TI6HLESSIMP
Not in Commercial Distribution

  • M268TI6HLESSIMP1 ()
  • 10381780074311 ()
TI6HLESSIMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
"Longer arm accommodates surgical burs Protects bur from being damaged during ultrasonic cleaning and sterilization Fits latch, friction grip and HP burs Drain holes on the bottom of the bur guard help prevent rusting on the burs One short bur adapter comes with one bur guard which enables long and short burs to be used in the same bur guard Dimensions: 2-7/8"" x 3/8"" x 1-5/8"" Autoclavable up to 136°C/275°F Washer-disinfect Contains Antimicrobial Protection Available in Gray Only"
ZIRC DENTAL PRODUCTS, INC.
50Z408I
In Commercial Distribution


  • Length: 73 Millimeter
  • Width: 9.5 Millimeter
  • Height: 41.3 Millimeter


  • Instrument transport trolley system
Vancomycin 30μg (Va30) HardyDisk™ Antimicrobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for many organisms. Vancomycin is indicated for in vitro activity against gram positive, aerobic microorganisms including Staphylococcus spp., Enterococcus spp., and Streptococcus spp. The vancomycin disk diffusion test alone is unsuitable for detection of decreased susceptibility to vancomycin in Staphylococcus aureus. The CDC has recommended to incorporate the vancomycin screen agar plate (BHI with vancomycin) for susceptibility testing of all S. aureus isolates. Alternatively, the screening may be limited to methicillin resistant S. aureus (MRSA) isolates, since nearly all vancomycin intermediate S. aureus (VISA) are known to be resistant to methicillin and oxacillin.
HARDY DIAGNOSTICS
Z9245
In Commercial Distribution

  • 00816576021086 ()
  • 00816576021819 ()
Z9245

  • Vancomycin susceptibility testing disc IVD
Vancomycin 30μg (Va30) HardyDisk™ Antimicrobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for many organisms. Vancomycin is indicated for in vitro activity against gram positive, aerobic microorganisms including Staphylococcus spp., Enterococcus spp., and Streptococcus spp. The vancomycin disk diffusion test alone is unsuitable for detection of decreased susceptibility to vancomycin in Staphylococcus aureus. The CDC has recommended to incorporate the vancomycin screen agar plate (BHI with vancomycin) for susceptibility testing of all S. aureus isolates. Alternatively, the screening may be limited to methicillin resistant S. aureus (MRSA) isolates, since nearly all vancomycin intermediate S. aureus (VISA) are known to be resistant to methicillin and oxacillin.
HARDY DIAGNOSTICS
Z9241
In Commercial Distribution

  • 00816576021079 ()
  • 00816576021819 ()
Z9241

  • Vancomycin susceptibility testing disc IVD
The Saccadometer Adavnced system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Advanced is equipped with three red laser projectors with 10º separation and green laser located centrally over the red. Eighteen experiments are included in embedded software. The information about the eye movement is stored in a small, self-contained control unit, and can be downloaded for computer analysis at a later stage. Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eye orbit are illuminated by two infrared LEDs, providing eye surface irradiance below 1mW/cm 2 (operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. Two eye landmarks are taking part in generation of the eye movement signal: the corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose.
OBER CONSULTING SP Z O O
ADVANCED
In Commercial Distribution

  • 05906874392027 ()


  • Eye movement analysis system
The Saccadometer Plus system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Plus is equipped with three red laser projectors with 10º separation, and 6 experiments are included in embedded software. The information about the eye movement is stored in a small, self-contained control unit, and can be downloaded for computer analysis at a later stage. Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eye orbit are illuminated by two infrared LEDs, providing eye surface irradiance below 1mW/cm 2 (operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. Two eye landmarks are taking part in generation of the eye movement signal: the corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose.
OBER CONSULTING SP Z O O
PLUS
In Commercial Distribution

  • 05906874392010 ()


  • Eye movement analysis system
The Integra Proximal Humeral Fracture Plate System is composed of this left reconstruction plate implant. The plate is made from stainless steel. The low profile humeral fracture plate is designed to sit lower on the greater tuberosity and is available in nine-hole.
Ascension Orthopedics, Inc.
HFP0930109LS
In Commercial Distribution

  • M269HFP0930109LS1 ()
  • 10381780120896 ()

  • 5.342 mm L
HFP0930109LS

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Proximal Humeral Fracture Plate System is composed of this right reconstruction plate implant. The plate is made from stainless steel. The low profile humeral fracture plate is designed to sit lower on the greater tuberosity and is available in nine-hole.
Ascension Orthopedics, Inc.
HFP0930109RS
In Commercial Distribution

  • M269HFP0930109RS1 ()
  • 10381780120889 ()

  • 5.342 mm L
HFP0930109RS

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Proximal Humeral Fracture Plate System is composed of this left reconstruction plate implant. The plate is made from stainless steel. The low profile humeral fracture plate is designed to sit lower on the greater tuberosity and is available in six-hole.
Ascension Orthopedics, Inc.
HFP0930106LS
In Commercial Distribution

  • 10381780120872 ()
  • M268HFP0930106LS1 ()

  • 4.405 mm L
HFP0930106LS

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
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