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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 Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobalt chloride and up to 2.0% N-Acetyl cysteine, in a ratio of 1:2. Zirconium oxide is sealed within the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is between 0.9 mm and 1.2 mm.
C4 IMAGING, LLC
F-01-03-0011
In Commercial Distribution

  • 00863593000242 ()


  • Radiological image marker, implantable
No Description
Biomet Orthopedics, LLC
31-109212
In Commercial Distribution

  • 00880304303782 ()

  • SIZE 25
31-109212

  • Orthopaedic implant aiming/guiding block, reusable
Team Sports First Aid Kit
LIFELINE FIRST AID, LLC
4409-B5
In Commercial Distribution

  • 00845174006683 ()


  • First aid kit, medicated
CAPNOSTAT 5 Mainstream CO2 Sensor
Respironics Novametrix, LLC
1154770
In Commercial Distribution

  • 00884838121409 ()
1154770

  • Patient monitoring system module, carbon dioxide
The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly effective for the concentration of urine for the detection of Bence Jones proteinuria found in patients with myelomatosis.
SARTORIUS STEDIM LAB LIMITED
VP0503
In Commercial Distribution

  • 05060602430143 ()
  • 05060602430365 ()


  • Laboratory dialyser
The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly effective for the concentration of urine for the detection of Bence Jones proteinuria found in patients with myelomatosis.
SARTORIUS STEDIM LAB LIMITED
VP0501
In Commercial Distribution

  • 05060602430129 ()
  • 05060602430365 ()


  • Laboratory dialyser
No Description
W.H. Holden, Inc.
10-4505
In Commercial Distribution

  • D9281045050 ()


  • Dental elevator, tooth/root
The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly effective for the concentration of urine for the detection of Bence Jones proteinuria found in patients with myelomatosis.
SARTORIUS STEDIM LAB LIMITED
VP0502
In Commercial Distribution

  • 05060602430136 ()
  • 05060602430365 ()


  • Laboratory dialyser
CATALYST 5 MANUAL WHEELCHAIR
KI MOBILITY, LLC
5
In Commercial Distribution

  • 00850013379026 ()


  • Push-rim manual wheelchair, non-bariatric
Eargo 5, 6 & 7 Charger
Eargo, Inc.
99-0141-001
In Commercial Distribution

  • 00850010429342 ()


  • Air-conduction hearing aid, in-the-ear
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