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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 Integra Freedom Wrist Arthroplasty radial component is made of Cobalt Chrome Molybdenum Alloy (CoCrMo) and has a concave articulating surface and is fixed by means of a stem which is inserted into the radial intramedullary canal.
Ascension Orthopedics, Inc.
348132E
In Commercial Distribution

  • M268348132E1 ()
  • 10381780066866 ()

  • 34.19 mm dia x 34.37 mm L; Size 3
348132E

  • Total wrist prosthesis
The Integra Freedom Wrist Arthroplasty radial component is made of Cobalt Chrome Molybdenum Alloy (CoCrMo) and has a concave articulating surface and is fixed by means of a stem which is inserted into the radial intramedullary canal.
Ascension Orthopedics, Inc.
348132
In Commercial Distribution

  • M2683481321 ()
  • 10381780066682 ()

  • 34.19 mm dia x 34.37 mm L; Size 3
348132

  • Total wrist prosthesis
The Integra Freedom Wrist Arthroplasty radial component is made of Cobalt Chrome Molybdenum Alloy (CoCrMo) and has a concave articulating surface and is fixed by means of a stem which is inserted into the radial intramedullary canal.
Ascension Orthopedics, Inc.
348122
In Commercial Distribution

  • M2683481221 ()
  • 10381780066668 ()

  • 31.17 mm dia x 30.49 mm L; Size 2
348122

  • Total wrist prosthesis
The Integra Freedom Wrist Arthroplasty radial component is made of Cobalt Chrome Molybdenum Alloy (CoCrMo) and has a concave articulating surface and is fixed by means of a stem which is inserted into the radial intramedullary canal.
Ascension Orthopedics, Inc.
348112
In Commercial Distribution

  • M2683481121 ()
  • 10381780066644 ()

  • 28.16 mm dia x 26.36 mm L; Size 1
348112

  • Total wrist prosthesis
The Integra Freedom Wrist Arthroplasty radial component is made of Cobalt Chrome Molybdenum Alloy (CoCrMo) and has a concave articulating surface and is fixed by means of a stem which is inserted into the radial intramedullary canal.
Ascension Orthopedics, Inc.
348111
In Commercial Distribution

  • M2683481111 ()
  • 10381780066637 ()

  • 28.16 mm dia x 26.36 mm L; Size 1
348111

  • Total wrist prosthesis
OnGuard2 Syringe Adaptor, 5 Units is part of the Chemfort CSTD system. The device distal end is intended to connect to Chemfort port (e.g., Vial Adaptor) The device Proximal end is intended to connect to luer syringe
SIMPLIVIA HEALTHCARE LTD
412188
In Commercial Distribution

  • 37290115921886 ()
  • 27290115921889 ()
  • 17290115921882 ()


  • Medication transfer set
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 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 50 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.
15mL
In Commercial Distribution

  • 00303786987894 ()


  • 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.
5mL
In Commercial Distribution

  • 00303786986019 ()


  • Inhalation therapy saline solution, hypertonic
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