SEARCH RESULTS FOR: hibcc(669032 results)

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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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CURE™ ACP - B167S1742141120

No Description
MEDITECH SPINE, LLC
S1-7-42141-12
In Commercial Distribution

  • B167S2742141121 ()
  • B167S4742141122 ()
  • B167S1742141120 ()


  • Spinal bone screw, non-bioabsorbable

CURE™ ACP - B167S1741245200

No Description
MEDITECH SPINE, LLC
S1-7-41245-20
In Commercial Distribution

  • B167S4741245202 ()
  • B167S2741245201 ()
  • B167S1741245200 ()


  • Spinal bone screw, non-bioabsorbable

CURE™ ACP - B167S1741245180

No Description
MEDITECH SPINE, LLC
S1-7-41245-18
In Commercial Distribution

  • B167S4741245182 ()
  • B167S2741245181 ()
  • B167S1741245180 ()


  • Spinal bone screw, non-bioabsorbable

CURE™ ACP - B167S1741245140

No Description
MEDITECH SPINE, LLC
S1-7-41245-14
In Commercial Distribution

  • B167S4741245142 ()
  • B167S2741245141 ()
  • B167S1741245140 ()


  • Spinal bone screw, non-bioabsorbable

CURE™ ACP - B167S1741245100

No Description
MEDITECH SPINE, LLC
S1-7-41245-10
In Commercial Distribution

  • B167S4741245102 ()
  • B167S2741245101 ()
  • B167S1741245100 ()


  • Spinal bone screw, non-bioabsorbable

CURE™ ACP - B167S1741241160

No Description
MEDITECH SPINE, LLC
S1-7-41241-16
In Commercial Distribution

  • B167S2741241161 ()
  • B167S4741241162 ()
  • B167S1741241160 ()


  • Spinal bone screw, non-bioabsorbable

CURE™ ACP - B167S1741241120

No Description
MEDITECH SPINE, LLC
S1-7-41241-12
In Commercial Distribution

  • B167S4741241122 ()
  • B167S2741241121 ()
  • B167S1741241120 ()


  • Spinal bone screw, non-bioabsorbable

CURE™ ACP - B167S1741145180

No Description
MEDITECH SPINE, LLC
S1-7-41145-18
In Commercial Distribution

  • B167S2741145181 ()
  • B167S4741145182 ()
  • B167S1741145180 ()


  • Spinal bone screw, non-bioabsorbable

CURE™ ACP - B167S1741145140

No Description
MEDITECH SPINE, LLC
S1-7-41145-14
In Commercial Distribution

  • B167S4741145142 ()
  • B167S2741145141 ()
  • B167S1741145140 ()


  • Spinal bone screw, non-bioabsorbable

CURE™ ACP - B167S1741145100

No Description
MEDITECH SPINE, LLC
S1-7-41145-10
In Commercial Distribution

  • B167S4741145102 ()
  • B167S2741145101 ()
  • B167S1741145100 ()


  • Spinal bone screw, non-bioabsorbable

CURE™ ACP - B167S1741141180

No Description
MEDITECH SPINE, LLC
S1-7-41141-18
In Commercial Distribution

  • B167S4741141182 ()
  • B167S2741141181 ()
  • B167S1741141180 ()


  • Spinal bone screw, non-bioabsorbable

CURE™ ACP - B167S1741141140

No Description
MEDITECH SPINE, LLC
S1-7-41141-14
In Commercial Distribution

  • B167S2741141141 ()
  • B167S4741141142 ()
  • B167S1741141140 ()


  • Spinal bone screw, non-bioabsorbable

InTray® PDA - B08812930

Recommended by the American Public Health Association for plate counts of yeasts and molds in the examination of foods and dairy products, it is also used for maintenance, cultivation and sporulation of stock cultures of various dermatophytes and for differentiation of atypical varieties of dermatophytes by pigment production.
BIO-MED DIAGNOSTICS, INC.
1293
In Commercial Distribution

  • B08812934 ()
  • B08812930 ()
  • B08812932 ()
21-293-001

  • Potato-dextrose fungal agar culture medium IVD

InTray® SAB - B08812630

A general-purpose medium for the cultivation of pathogenic and non-pathogenic fungi, including dermatophytes. The low pH (approximately 5.6) is favorable for growth of fungi, especially yeasts and dermatophytes. Sabouraud's Dextrose Agar (SAB) is slightly inhibitory to contaminating bacteria in clinical specimens.
BIO-MED DIAGNOSTICS, INC.
1263
In Commercial Distribution

  • B08812634 ()
  • B08812630 ()
  • B08812632 ()
21-263-001

  • Basic/simple nutrient agar culture medium IVD

InTray® COLOREX Salmonella - B08812230

A chromogenic medium for selective isolation and differentiation of Salmonella species, (e.g., Enterobacteriaceae and other enteric bacteria).The test can be performed with samples composed of mixed populations of bacteria, e.g stool, blood, biological fluids, surface streaks, etc. High sensitivity and specificity of the medium lead to a higher detection rate of Salmonella spp. Selective agents inhibit the growth of gram-positive organisms. Artificial substrates are metabolized by specific microbial enzymes liberating insoluble chromogenic compounds. Salmonella species produce deep pink to mauve colored colonies. Bacteria other than Salmonella spp. produce blue colonies, or are colorless or inhibited.
BIO-MED DIAGNOSTICS, INC.
1223
In Commercial Distribution

  • B08812234 ()
  • B08812230 ()
  • B08812232 ()
21-223-001

  • Chromogenic Salmonella species agar culture medium IVD

InTray® COLOREX Yeast - B08811130

For isolation and differentiation of major clinically significant Candida species. Suitable for direct streaking of samples from skin,sputum, urine or genitourinary swabs.
BIO-MED DIAGNOSTICS, INC.
1113
In Commercial Distribution

  • B08811134 ()
  • B08811130 ()
  • B08811132 ()
21-113-001

  • Multiple Candida/yeast species culture isolate identification IVD, kit

InTray® COLOREX Screen - B08811030

For rapid isolation and differentiation of urinary tract pathogens. Suitable for direct plating of urine specimens.
BIO-MED DIAGNOSTICS, INC.
1103
In Commercial Distribution

  • B08811034 ()
  • B08811030 ()
  • B08811032 ()
21-103-001

  • Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid

SPINR - B090SPN10050

Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature
ZIEN MEDICAL TECHNOLOGIES, INC.
SPN-1005
In Commercial Distribution

  • B090SPN10051 ()
  • B090SPN10050 ()
  • B090SPN10052 ()
SPN-1005

  • Torque manipulation device

XO Score - B090S6500650

The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
S6.50-065
In Commercial Distribution

  • B090S6500651 ()
  • B090S6500650 ()
  • B090S6500652 ()

  • Catheter Working Length: 65 Centimeter
  • Introducer Sheath Compatibility: 7 French
  • Catheter Gauge: 6.4 French
  • Scoring Depth, 0.50mm
S6.50-065

  • Peripheral angioplasty balloon catheter, basic

XO Score - B090S6250650

The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
S6.25-065
In Commercial Distribution

  • B090S6250650 ()
  • B090S6250651 ()
  • B090S6250652 ()

  • Catheter Working Length: 65 Centimeter
  • Introducer Sheath Compatibility: 7 French
  • Catheter Gauge: 6.4 French
  • Scoring Depth, 0.25mm
S6.25-065

  • Peripheral angioplasty balloon catheter, basic
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