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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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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
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
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
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
Self-contained media system for the recovery and detection of T. vaginalis from female vaginal samples or male urethra/urine samples.
BIO-MED DIAGNOSTICS, INC.
1031
In Commercial Distribution

  • B08810310 ()
  • B08810317 ()
  • B08810313 ()
21-031-001

  • Differential/selective broth culture medium IVD
Locking Cap
Kalitec Direct LLC
11-LCL-0000
In Commercial Distribution

  • B07311LCL00000 ()
  • B07311LCL00002 ()
  • B07311LCL00001 ()


  • Spinal bone set screw
Micro Applicators Regular (2.00mm) Purple
Bright Supply, Inc.
BSI-1501
In Commercial Distribution

  • D974BSI20032 ()
  • D974BSI20031 ()
  • D974BSI20033 ()
  • D974BSI20030 ()


  • Dental material application tool, single-use
The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-090
Not in Commercial Distribution

  • B090C140901 ()
  • B090C140900 ()
  • B090C140902 ()

  • Catheter Working Length: 90 Centimeter
  • Crossing Profile: 1.6 French
  • Catheter Gauge: 2 French
  • Introducer Sheath Compatibility: 2.9 French
C14-090

  • Vascular guide-catheter, single-use
The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-135
Not in Commercial Distribution

  • B090C351351 ()
  • B090C351350 ()
  • B090C351352 ()

  • Catheter Gauge: 3.9 French
  • Catheter Working Length: 135 Centimeter
  • Crossing Profile: 3.2 French
  • Introducer Sheath Compatibility: 4 French
C35-135

  • Vascular guide-catheter, single-use
The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-175
Not in Commercial Distribution

  • B090C141751 ()
  • B090C141750 ()
  • B090C141752 ()

  • Catheter Gauge: 2 French
  • Introducer Sheath Compatibility: 2.9 French
  • Catheter Working Length: 175 Centimeter
  • Crossing Profile: 1.6 French
C14-175

  • Vascular guide-catheter, single-use
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