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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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Tourny Infant\X-Maxi White\8"
Batrik Medical Manufacturing Inc
910-1113-8
In Commercial Distribution

  • 00690521011014 ()


  • Limb tourniquet, manual, single-use
IBEX Wireless LED Binocular Indirect Ophthalmoscope is a specialized microscope that provides stereoscopic, wide-angled, high resolution views of the entire fundus and overlying vitreous. Its optical principles and illumination system allows for visualization of the fundus regardless of high ametropia, hazy ocular media or central opacities.
Trevi Technology, Inc.
BIO
In Commercial Distribution

  • 00869228000434 ()


  • Indirect binocular ophthalmoscope, line-powered
OrthoMTA is ideal for orthograde root canal grafting material especially for file separation, crack tooth syndrome, severely infected canal, and re-endo of acute periapical abscess. Furthermore, OrthoMTA has a wide variety of clinical indications such as for apexification, repair of root perforations, and internal root resporption.
BioMTA
OM50
In Commercial Distribution

  • 08800027200078 ()


  • Endodontic filling/sealing material
OrthoMTA is ideal for orthograde root canal grafting material especially for file separation, crack tooth syndrome, severely infected canal, and re-endo of acute periapical abscess. Furthermore, OrthoMTA has a wide variety of clinical indications such as for apexification, repair of root perforations, and internal root resporption.
BioMTA
OM05
In Commercial Distribution

  • 08800027200061 ()


  • Endodontic filling/sealing material
The Sure + 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, urge, and mixed urinary incontinence in women and to maintain urinary continence in women. The Sure + is intended for OTC use.
TENSCARE LIMITED
Sure+
In Commercial Distribution

  • 05033435134458 ()
K-SURE+USA

  • Perineal orifice incontinence-control electrical stimulation system
MIC Tests Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Azithromycin 0.016-256 µg/mL are specialized strips impregnated with a predefined concentration gradient of Azithromycin for susceptibility testing of Staphylococcus aureus (methicillin-susceptible strains)
LIOFILCHEM SRL
Azithromycin 0.016-256 µg/mL 1 Strip
In Commercial Distribution

  • 28055182871241 ()
  • 08055182871247 ()
  • 18055182871244 ()
$92030-1

  • Azithromycin minimum inhibitory concentration (MIC) IVD
MIC Tests Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Azithromycin 0.016-256 µg/mL are specialized strips impregnated with a predefined concentration gradient of Azithromycin for susceptibility testing of Staphylococcus aureus (methicillin-susceptible strains)
LIOFILCHEM SRL
Azithromycin 0.016-256 µg/mL 10 Strips
In Commercial Distribution

  • 18055182871251 ()
  • 08055182871254 ()
  • 08055182871230 ()
$92030-10

  • Azithromycin 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 Clindamycin 0.016-256 µg/mL are specialized strips impregnated with a predefined concentration gradient of Clindamycin for susceptibility testing of Staphylococcus aureus (methicillin-susceptible strains).
LIOFILCHEM SRL
Clindamycin 0.016-256 µg/mL 10 strips
In Commercial Distribution

  • 18055182870148 ()
  • 08055182870141 ()
  • 08055182870127 ()
$92072-10

  • Clindamycin 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 Clindamycin 0.016-256 µg/mL are specialized strips impregnated with a predefined concentration gradient of Clindamycin for susceptibility testing of Staphylococcus aureus (methicillin-susceptible strains).
LIOFILCHEM SRL
Clindamycin 0.016-256 µg/mL 1 strip
In Commercial Distribution

  • 28055182870138 ()
  • 08055182870134 ()
  • 18055182870131 ()
$92072-1

  • Clindamycin minimum inhibitory concentration (MIC) IVD
The Integra® DigiFuse® Implant is a one-piece threaded device constructed from implant grade titanium alloy, intended to be implanted into the medullary bone for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers.
Ascension Orthopedics, Inc.
DF2510
In Commercial Distribution

  • 10381780120049 ()
  • M268DF25101 ()

  • 24.22 mm L x 2.50 mm dia; 0 degree angle
DF2510

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