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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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Restorative Kit 10.5
Quadric Biomed, LLC
KRS10.5
In Commercial Distribution

  • D985KRS1050 ()


  • Dental implant suprastructure, permanent, preformed
Tissue Forming Kit 9.1
Quadric Biomed, LLC
KTF9.1
In Commercial Distribution

  • D985KTF910 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Tissue Forming Kit 10.5
Quadric Biomed, LLC
KTF10.5
In Commercial Distribution

  • D985KTF1050 ()


  • Dental implant suprastructure, temporary, preformed, single-use
No Description
Quadric Biomed, LLC
KSG9.1
In Commercial Distribution

  • D985KSG910 ()


  • Dental implant system
No Description
Quadric Biomed, LLC
KSG10.5
In Commercial Distribution

  • D985KSG1050 ()


  • Dental implant system
The product is intended for the quantitative in vitro determination of Lithium in serum.
RANDOX LABORATORIES LIMITED
LM4005
In Commercial Distribution

  • 05055273209143 ()
LM4005

  • Lithium therapeutic drug monitoring IVD, reagent
Revascularization Device
Micro Therapeutics, Inc.
SFR2-4-40
In Commercial Distribution

  • 00847536003323 ()

  • Outer Diameter: 4 Millimeter
  • Length: 50 Millimeter
  • Usable Length,40,Millimeter;Push Wire Length,180,Centimeter;
SFR2-4-40

  • Bare-metal intracranial vascular stent
F2 CATHETER FG PKG
Bayer Healthcare LLC
109400-001
In Commercial Distribution

  • 00616258003955 ()

  • Catheter Gauge: 6 French
109400

  • Thrombectomy suction catheter
Radiation therapy QA device.
SUN NUCLEAR CORP.
1174300Z
In Commercial Distribution

  • 05060608880140 ()
11740000Z

  • Accelerator system quality assurance device
Radiation therapy QA device.
SUN NUCLEAR CORP.
1137000-0Z
In Commercial Distribution

1137000-0Z

  • Solid-state-semiconductor radiation measuring probe
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