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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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No Description
AGFA
DM 2 B 35x43
In Commercial Distribution

  • 05414904224786 ()
  • 05414904005026 ()
  • 05414904224779 ()

  • Width: 43 Centimeter
  • Length: 35 Centimeter
EP1ND

  • Medical printer film
Metal Lined Cermic Twin ROTH .018 LL3 -11°T +5°A 5PK
Flexmedics
50-L3-8L-V
In Commercial Distribution

  • 00195291003776 ()
  • 10195291003773 ()


  • Orthodontic bracket, ceramic
The DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that connects to the user's PC via USB connection. The DGH 8000 uses ultrasonic pulse technology to create 2-dimensional, cross-section images of the human eye.
DGH TECHNOLOGY INC.
DGH 8000
In Commercial Distribution

  • 00857377006100 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
The product is intended to be used as a second Calibrator in a two-point calibration. Calibrator B is aspirated from a sample cup at position 18 on the analyser ASP tray at least once every 8 hours depending on the laboratories schedule.
RANDOX LABORATORIES LIMITED
RX3949
In Commercial Distribution

  • 05055273205954 ()
RX3949

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Cryopreservation storage devices that are intended for use in vitrificationprocedures to contain and maintain human oocytes (MII) and embryos.
KITAZATO CORPORATION
CryotopUS-scoop(B)
In Commercial Distribution

  • 14582231462879 ()
  • 04582231462872 ()
81198

  • Assisted reproduction vitrification carrier
Cryopreservation storage devices that are intended for use in vitrificationprocedures to contain and maintain human oocytes (MII) and embryos.
KITAZATO CORPORATION
CryotopUS-flash(B)
In Commercial Distribution

  • 14582231462824 ()
  • 04582231462827 ()
81184

  • Assisted reproduction vitrification carrier
No Description
KITAZATO CORPORATION
CryotopUS(B)
In Commercial Distribution

  • 14582231462503 ()
  • 04582231462506 ()
  • 14582231462558 ()


  • Assisted reproduction vitrification carrier
No Description
KITAZATO CORPORATION
CryotopCL(G)
In Commercial Distribution

  • 14582231461988 ()
  • 04582231461981 ()


  • Assisted reproduction vitrification carrier
No Description
KITAZATO CORPORATION
CryotopSC(B)
In Commercial Distribution

  • 14582231461933 ()
  • 04582231461936 ()


  • Assisted reproduction vitrification carrier
No Description
BIOCARE MEDICAL LLC
ACI3202A
In Commercial Distribution

  • 00847627003607 ()


  • Lactoferrin IVD, antibody
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