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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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DIM Analog
NT-Trading GmbH & Co. KG
MIC 5.DIM.330
In Commercial Distribution

  • ENTTMIC5DIM3301 ()

  • DIM Analog Ø 3,3 mm
MIC 5.DIM.330

  • Dental implant suprastructure, temporary, preformed, single-use
DIM Analog
NT-Trading GmbH & Co. KG
MEX 5.DIM.414
In Commercial Distribution

  • ENTTMEX5DIM4141 ()

  • DIM Analog Ø 3,75 - 4,8 mm
MEX 5.DIM.414

  • Dental implant suprastructure, temporary, preformed, single-use
DIM Analog
NT-Trading GmbH & Co. KG
MEG 5.DIM.355
In Commercial Distribution

  • ENTTMEG5DIM3551 ()

  • DIM Analog Ø 3,5 - 5,5 mm
MEG 5.DIM.355

  • Dental implant suprastructure, temporary, preformed, single-use
DIM Analog
NT-Trading GmbH & Co. KG
ISY 5.DIM.350
In Commercial Distribution

  • ENTTISY5DIM3501 ()

  • DIM Analog Ø 3,5 mm
ISY 5.DIM.350

  • Dental implant suprastructure, temporary, preformed, single-use
DIM Analog
NT-Trading GmbH & Co. KG
I 5.DIM.340
In Commercial Distribution

  • ENTTI5DIM3401 ()

  • DIM Analog Ø 3,4 mm
I 5.DIM.340

  • Dental implant suprastructure, temporary, preformed, single-use
DIM Analog
NT-Trading GmbH & Co. KG
F 5.DIM.435
In Commercial Distribution

  • ENTTF5DIM4351 ()

  • DIM Analog Ø 4,3 - 5,0 mm RP
F 5.DIM.435

  • Dental implant suprastructure, temporary, preformed, single-use
DIM Analog
NT-Trading GmbH & Co. KG
F 5.DIM.350
In Commercial Distribution

  • ENTTF5DIM3501 ()

  • DIM Analog Ø 3,5 mm NP
F 5.DIM.350

  • Dental implant suprastructure, temporary, preformed, single-use
5FR MICRO INTRODUCER KIT
STRADIS MEDICAL, LLC
525-155
Not in Commercial Distribution

  • M7525251551 ()

  • Catheter Gauge: 5 French


  • Vascular catheter introduction set, nonimplantable
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-500DX
In Commercial Distribution

  • M729700500DX1 ()
  • M729700500DX0 ()
  • M729700500DX3 ()

  • Catheter Gauge: 5 French


  • Femoral artery closure plug/patch, collagen
SIR-Y001 (3Gbq/5ml): SIR-Spheres Y-90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 3 GBq of Y90 ± 10% (at the time of calibration) in a total of 5 cc water for injection. Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value. SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.
SIRTEX MEDICAL PTY LTD
SIR-Y001
In Commercial Distribution


  • Total Volume: 5 Milliliter


  • Manual brachytherapy source, permanent implant
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