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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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The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures. The i-Cut is electrically operated by a DC Motor which is powered by a 24V AC/DC mains adapter. The non-sterile i-Cut Power Supply with power cord is supplied separately to power the device.
AMI Agency for Medical Innovations GmbH
ICT5010
In Commercial Distribution

  • EAMIICT50100 ()


  • Basic power supply, reusable
The Blowfish Transbronchial Micro-Infusion Catheter is a bronchoscope-guided device that contains a perpendicular stainless steel micro-needle port. This port is sheathed by and contained within a semi-rigid polymer actuator, which is connected to the flexible shaft. At the proximal end of the catheter shaft is the hub assembly.
MERCATOR MEDSYSTEMS, INC.
MDL09-0616-145-HT
In Commercial Distribution

  • M973BL06161 ()
BH201M

  • Vascular microcatheter
  • Bronchial balloon catheter
The Blowfish Transbronchial Micro-Infusion Catheter is a bronchoscope-guided device that contains a perpendicular stainless steel micro-needle port. This port is sheathed by and contained within a semi-rigid polymer actuator, which is connected to the flexible shaft. At the proximal end of the catheter shaft is the hub assembly.
MERCATOR MEDSYSTEMS, INC.
MDL09-0616-145-34
Not in Commercial Distribution

  • M973BH201M1 ()
BH201M

  • Vascular microcatheter
  • Bronchial balloon catheter
CitriSol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
CSP45225-75100
In Commercial Distribution

  • B467CSP4522575100 ()
  • B467CSP452257510016 ()
CSP3

  • Haemodialysis concentrate
Paste used to polish teeth after dental restoration is complete
Bioclear Matrix Systems
Mint
In Commercial Distribution

  • D9497001111 ()


  • Dentifrice
The EsoSure Esophageal Retractor is intended to move the esophagus.
NORTH EAST SCIENTIFIC INC
100001
In Commercial Distribution


  • Outer Diameter: 0.109 Inch
100001

  • Intraluminal oesophageal retractor
Wrong Listing no was used, the correct one is D347385
JK-Products GmbH
JK 158 / 48-0
In Commercial Distribution

  • EJKP100003492A0 ()


  • Ultraviolet tanning device
Wrong Listing no was used, the correct one is D347385
JK-Products GmbH
JK 158 / 48-0 VS
In Commercial Distribution

  • EJKP100003491A0 ()


  • Ultraviolet tanning device
Wrong Listing no was used, the correct one is D347385
JK-Products GmbH
JK 158 / 48-0
In Commercial Distribution

  • EJKP100003490A0 ()


  • Ultraviolet tanning device
Wrong Listing no was used, the correct one is D347385
JK-Products GmbH
JK 158 / 48-0
In Commercial Distribution

  • EJKP100003460A0 ()


  • Ultraviolet tanning device
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