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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 single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy. The device contains no preservative and is sterile and pyrogen free. Primary DI number is for one carton of 100 vials, the lowest saleable unit. Each vial is not sold separately and is not intended to be separated from it's unit of sale.
Mylan Pharmaceuticals Inc.
5mL
In Commercial Distribution

  • 00303786986019 ()


  • Inhalation therapy saline solution, hypertonic
The single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy. The device contains no preservative and is sterile and pyrogen free. Primary DI number is for one carton of 100 vials, the lowest saleable unit. Each vial is not sold separately and is not intended to be separated from it's unit of sale.
Mylan Pharmaceuticals Inc.
3mL
In Commercial Distribution

  • 00303786985012 ()


  • Inhalation therapy saline solution, hypertonic
The ETO Sterilized Curette is used to obtain a sample of differentiated endometrial tissue. The Curette is a 3mm (O.D.) endometrial suction curette with a Randall-like cutting edge at its distal end and packaged with a twist-and-lock syringe. The syringe provides the vacuum or suction during the procedure. The Curette is sterile unless the package is opened or damaged. It is designed for single patient use only.
PANPAC MEDICAL CORPORATION
RD003-W
In Commercial Distribution

  • 04715309129395 ()
  • 04715309129449 ()


  • Endometrial biopsy kit
The ETO Sterilized Curette is used to obtain a sample of differentiated endometrial tissue. The Curette is a 3mm (O.D.) endometrial suction curette with a Randall-like cutting edge at its distal end and packaged with a twist-and-lock syringe. The syringe provides the vacuum or suction during the procedure. The Curette is sterile unless the package is opened or damaged. It is designed for single patient use only.
PANPAC MEDICAL CORPORATION
RD003
In Commercial Distribution

  • 04715309121993 ()
  • 04715309124994 ()


  • Endometrial biopsy kit
The LipoGrafter kit is a sterile, single use disposable device that is used in harvesting, sedimenting, and transferring autologous fat to the desired anatomy.
Musculoskeletal Transplant Foundation, Inc.
913000
In Commercial Distribution

  • 00859070006050 ()


  • General-purpose syringe, single-use
The ICHOR embolectomy system is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The device is intended for peripheral vasculature
ICHOR VASCULAR, INC.
ICH14FR
In Commercial Distribution

  • 00860010378007 ()

  • Catheter Gauge: 14F French


  • Thrombectomy balloon catheter
The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
FOCAL THERAPEUTICS, INC.
F0331
Not in Commercial Distribution

  • 00851766006085 ()

  • Width: 3 Centimeter
  • Length: 3 Centimeter
  • Height: 1 Centimeter


  • Radiological image marker, implantable
The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
FOCAL THERAPEUTICS, INC.
F0231
Not in Commercial Distribution

  • 00851766006078 ()

  • Width: 2 Centimeter
  • Length: 3 Centimeter
  • Height: 1 Centimeter


  • Radiological image marker, implantable
The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
FOCAL THERAPEUTICS, INC.
F0221
Not in Commercial Distribution

  • 00851766006061 ()

  • Width: 2 Centimeter
  • Length: 2 Centimeter
  • Height: 1 Centimeter


  • Radiological image marker, implantable
The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
FOCAL THERAPEUTICS, INC.
F0405
Not in Commercial Distribution

  • 00851766006054 ()

  • Length: 5 Centimeter
  • Width: 4 Centimeter


  • Radiological image marker, implantable
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