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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 L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. System includes one TST-11 tip.
3shape Trios A/S
L1P-1F
In Commercial Distribution

  • 05902729754149 ()


  • Intraoral optical scanning system
No Description
3shape Trios A/S
L1-2
In Commercial Distribution

  • 05902729753739 ()


  • Intraoral optical scanning system
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. System includes five TST-11 tips.
3shape Trios A/S
L1P-1F
In Commercial Distribution

  • 05902729753722 ()


  • Intraoral optical scanning system
Constriction Ring
AUGUSTA MEDICAL SYSTEMS, L.L.C.
Constriction Ring
In Commercial Distribution

  • 00852598007349 ()


  • Penile vacuum device
Constriction Ring
AUGUSTA MEDICAL SYSTEMS, L.L.C.
Constriction Ring
In Commercial Distribution

  • 00852598007318 ()


  • Penile vacuum device
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
VP0502
In Commercial Distribution

  • 05060602430136 ()
  • 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
Biomedica ADI Inc.
815
In Commercial Distribution

  • 00850201006024 ()
  • 10850201006021 ()
815

  • Lupus anticoagulant marker IVD, kit, clotting
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 1.0 mm. It is loaded in an implant needle and sterilized with Ethylene Oxide.
C4 IMAGING, LLC
F-01-03-0111
In Commercial Distribution

  • 00863593000259 ()


  • Radiological image marker, implantable
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