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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 Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The cervical rasps are available in parallel and lordotic configurations, 14mmX11mm and 17mmX13mm sizes and thicknesses between 5mm and 11mm.
BLUSTONE SYNERGY, LLC
9014-CRL8
In Commercial Distribution

  • 00810482030873 ()

  • Height: 8 Millimeter
  • Width: 11 Millimeter
  • Length: 14 Millimeter


  • Bone file
The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The cervical rasps are available in parallel and lordotic configurations, 14mmX11mm and 17mmX13mm sizes and thicknesses between 5mm and 11mm.
BLUSTONE SYNERGY, LLC
9014-CRL7
In Commercial Distribution

  • 00810482030866 ()

  • Height: 7 Millimeter
  • Width: 11 Millimeter
  • Length: 14 Millimeter


  • Bone file
The BluStone Synergy Cervical Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The cervical rasps are available in 11mmX14mm and 13mmX17mm footprints, lordotic and parallel configurations, and thicknesses from 5mm to 11mm.
BLUSTONE SYNERGY, LLC
9014-CRP5
In Commercial Distribution

  • 00810482030910 ()

  • Height: 5 Millimeter
  • Width: 11 Millimeter
  • Length: 14 Millimeter


  • Bone file
The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. The instrumentation is manufactured from biocompatible materials. The rear foot plates include lapidus plates, interpositioning plates, universal rear foot plates, rear foot reconstruction plates, flat line arthrodesis plates, dwyer displacement plates, calcaneus plates, and fibular plates.
Ascension Orthopedics, Inc.
TFSREARFTIMP
Not in Commercial Distribution

  • M268TFSREARFTIMP1 ()
  • 10381780064596 ()
TFSREARFTIMP

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Orthopedic bone wire intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1020-1030
In Commercial Distribution

  • 07640136270293 ()


  • Orthopaedic bone wire
STAT-Site® Diluent is intended to be used with the STAT-Site® M β-HB Test Strips or KetoSite® Test Cards to dilute specimens containing high levels of β-hydroxybutyrate into the test range of 0 – 2 mM. Additionally, the diluent helps to eliminate possible matrix effects caused by interfering substances such as acetoacetate.
STANBIO LABORATORY, L.P.
202000
In Commercial Distribution

  • 00657498000120 ()
202000

  • Buffered sample diluent IVD, manual
MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Telavancin 0.016-256 µg/mL are specialized strips impregnated with a predefined concentration gradient of Telavancin for susceptibility testing of Staphylococcus aureus (including methicillin-resistant isolates), Enterococcus faecalis (vancomycin-susceptible isolates only).
LIOFILCHEM SRL
Telavancin 0.016-256 µg/mL 10 strips
In Commercial Distribution

  • 18055182870230 ()
  • 08055182870233 ()
  • 08055182870219 ()
$92053-10

  • Telavancin minimum inhibitory concentration (MIC) IVD
MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Telavancin 0.016-256 µg/mL are specialized strips impregnated with a predefined concentration gradient of Telavancin for susceptibility testing of Staphylococcus aureus (including methicillin-resistant isolates), Enterococcus faecalis (vancomycin-susceptible isolates only).
LIOFILCHEM SRL
Telavancin 0.016-256 µg/mL 1 strip
In Commercial Distribution

  • 28055182870220 ()
  • 08055182870226 ()
  • 18055182870223 ()
$92053-1

  • Telavancin minimum inhibitory concentration (MIC) IVD
MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Vancomycin 0.016-256 μg/mL are specialized strips impregnated with a predefined concentration gradient of vancomycin for susceptibility testing of nonfastidious species, Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis and Enterococcus faecium.
LIOFILCHEM SRL
Vancomycin 0.016-256 µg/ml 10 strips
In Commercial Distribution

  • 18055182870056 ()
  • 08055182870059 ()
  • 08055182870035 ()
$92057-10

  • Vancomycin minimum inhibitory concentration (MIC) IVD
MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Vancomycin 0.016-256 μg/mL are specialized strips impregnated with a predefined concentration gradient of vancomycin for susceptibility testing of nonfastidious species, Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis and Enterococcus faecium.
LIOFILCHEM SRL
Vancomycin 0.016-256 µg/ml 1 strip
In Commercial Distribution

  • 28055182870046 ()
  • 08055182870042 ()
  • 18055182870049 ()
$92057-1

  • Vancomycin minimum inhibitory concentration (MIC) IVD
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