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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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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
Smoke Aspiration Tip
IMPLANTECH ASSOCIATES, INC.
SE-100
In Commercial Distribution

  • M724SE100102 ()
  • M724SE1001 ()
  • M724SE100252 ()
SE-100

  • Surgical plume evacuation system tube
The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
E20-130-S
In Commercial Distribution

  • B090E20130S1 ()
  • B090E20130S0 ()
  • B090E20130S2 ()

  • Catheter Length: 130 Centimeter
  • Catheter Gauge: 2 French
E20-130-S

  • Vascular microcatheter
The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
E20-130-B
In Commercial Distribution

  • B090E20130B1 ()
  • B090E20130B0 ()
  • B090E20130B2 ()

  • Catheter Length: 130 Centimeter
  • Catheter Gauge: 2 French
E20-130-B

  • Vascular microcatheter
The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
2P0-130-S
In Commercial Distribution

  • B0902P0130S1 ()
  • B0902P0130S0 ()
  • B0902P0130S2 ()

  • Catheter Length: 130 Centimeter
  • Catheter Gauge: 2 French
2P0-130-S

  • Vascular microcatheter
The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
2P0-130-B
In Commercial Distribution

  • B0902P0130B1 ()
  • B0902P0130B0 ()
  • B0902P0130B2 ()

  • Catheter Length: 130 Centimeter
  • Catheter Gauge: 2 French
2P0-130-B

  • Vascular microcatheter
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-580I
In Commercial Distribution

  • M729700580I1 ()
  • M729700580I0 ()
  • M729700580I3 ()

  • Catheter Gauge: 7 French
  • Catheter Gauge: 6 French


  • Femoral artery closure plug/patch, collagen
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-500DX
In Commercial Distribution

  • M729700500DX1 ()
  • M729700500DX0 ()
  • M729700500DX3 ()

  • Catheter Gauge: 5 French


  • Femoral artery closure plug/patch, collagen
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