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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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3.0mm Correction L-Bunion Plate. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
BUN-PLT-03
In Commercial Distribution

  • 00810005669344 ()

  • Height: 3.0 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
5.0mm Correction L-Bunion Plate. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
BUN-PLT-05
In Commercial Distribution

  • 00810005665704 ()

  • Height: 5.0 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Kegel Toner is a powered muscle stimulator used for strengthening the pelvic floor muscles. The Kegel Toner is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women.
TENSCARE LIMITED
Kegel Toner
In Commercial Distribution

  • 05033435134021 ()
K-KT

  • Perineal orifice incontinence-control electrical stimulation system
MTS is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Penicillin G 0.002-32 µg/mL are specialized strips impregnated with a predefined concentration gradient of Penicillin G for susceptibility testing of Streptococcus ssp.
LIOFILCHEM SRL
PENICILLIN G P 0.002-32 µg/mL 10 Strip
In Commercial Distribution

  • 18055182872876 ()
  • 08055182872879 ()
  • 08055182872855 ()
$92103-10

  • Penicillin G minimum inhibitory concentration (MIC) IVD
MTS is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Penicillin G 0.002-32 µg/mL are specialized strips impregnated with a predefined concentration gradient of Penicillin G for susceptibility testing of Streptococcus ssp.
LIOFILCHEM SRL
PENICILLIN G P 0.002-32 µg/mL 1 Strip
In Commercial Distribution

  • 28055182872866 ()
  • 08055182872862 ()
  • 18055182872869 ()
$92103-1

  • Penicillin G 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 Erythromycin 0.016 - 256μg/m are specialized strips impregnated with a predefined concentration gradient of Erythromycin for susceptibility testing of Staphylococcus aureus.
LIOFILCHEM SRL
Erythromycin 0.016 - 256μg/mL 10 strips
In Commercial Distribution

  • 18055182870292 ()
  • 08055182870295 ()
  • 08055182870271 ()
$92051-10

  • Erythromycin 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 Erythromycin 0.016 - 256μg/m are specialized strips impregnated with a predefined concentration gradient of Erythromycin for susceptibility testing of Staphylococcus aureus.
LIOFILCHEM SRL
Erythromycin 0.016 - 256μg/mL 1 strip
In Commercial Distribution

  • 28055182870282 ()
  • 08055182870288 ()
  • 18055182870285 ()
$92051-1

  • Erythromycin minimum inhibitory concentration (MIC) IVD
The ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings.
ELITECHGROUP INC.
Model 3400
In Commercial Distribution

  • 03661540304088 ()


  • Chloride coulometric titration analyser IVD, semi-automated
The Osseus Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Osseus Fusion Systems, LLC
1001-0000
In Commercial Distribution

  • 71341402JV ()
  • B062100100000J ()

  • Length: 300 Millimeter
  • Length: 250 Millimeter
  • Length: 200 Millimeter
  • Length: 120 Millimeter
  • Length: 115 Millimeter
  • Length: 110 Millimeter
  • Length: 105 Millimeter
  • Length: 40 Millimeter
  • Length: 35 Millimeter
  • Length: 30 Millimeter
  • Outer Diameter: 8.5 Millimeter
  • Outer Diameter: 7.5 Millimeter
  • Outer Diameter: 6.5 Millimeter
  • Outer Diameter: 5.5 Millimeter
  • Outer Diameter: 4.5 Millimeter
  • Depth: 90 Millimeter
  • Depth: 70 Millimeter
  • Depth: 50 Millimeter
  • Depth: 35 Millimeter
  • Depth: 30 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
  • Length: 65 Millimeter
  • Length: 70 Millimeter
  • Length: 75 Millimeter
  • Length: 80 Millimeter
  • Length: 85 Millimeter
  • Length: 90 Millimeter
  • Length: 95 Millimeter
  • Length: 100 Millimeter
1001-0000 to 1010-9999

  • Bone-screw internal spinal fixation system, non-sterile
The Integra Ti6 Internal Fixation System is comprised of Digital screws used for bone fixation of the hand and foot following trauma or osteotomy. The Digital Screw is a cannulated, threaded bone screw which is offered in a 2.0mm diameter with lengths of 24 to 50mm. The system includes titanium and stainless steel instruments to facilitate the placement of the screws.
Ascension Orthopedics, Inc.
TI6DIGITIMP
Not in Commercial Distribution

  • M268TI6DIGITIMP1 ()
  • 10381780074304 ()
TI6DIGITIMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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