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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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CATH 076586 RFMARINR 5F SCXXL W/O CE
MEDTRONIC, INC.
076586
In Commercial Distribution

  • 00763000227630 ()

  • Electrode spacing 2.5.2 mm
  • Catheter deflectable tip length 65 mm
  • Catheter usable length 80 cm
  • Catheter distal electrode size 4 mm
  • Catheter size 1.7mm (5 Fr)


  • Cardiac radio-frequency ablation system catheter
DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 5 year battery pack with 9V Lithium battery (DCF-200), alarmed wall mount cabinet (DAC-220), rescue pack (DAC-420), 3-way wall sign (DAC-230), soft carry case (DAC-100), pediatric pads (DDP-200P), prescription activation form
DEFIBTECH, L.L.C.
CCPRX-0003
In Commercial Distribution

  • 00815098020805 ()


  • Non-rechargeable public semi-automated external defibrillator
CATH 70257533 CONTACTR 5MM US W/O CE
MEDTRONIC, INC.
70257533
Not in Commercial Distribution

  • 00643169139428 ()

  • Catheter distal electrode size 2.7 mm (8 Fr)
  • Catheter size 7 Fr
  • Catheter deflectable tip length 75 mm
  • Catheter usable length 110 cm
  • Catheter electrode size 5 mm


  • Cardiac radio-frequency ablation system catheter
CATH 70256034 CONTACTR 5MM US W/O CE
MEDTRONIC, INC.
70256034
Not in Commercial Distribution

  • 00643169139411 ()

  • Catheter electrode size 5 mm
  • Catheter deflectable tip length 60 mm
  • Catheter distal electrode size 2.7 mm (8 Fr)
  • Catheter size 7 Fr
  • Catheter usable length 110 cm


  • Cardiac radio-frequency ablation system catheter
The intended purpose is for certified surgeons, to conduct the surgical procedure for Abutment Extraction, facilitate removal of Abutment and Abutment Screw within an OPRA™ Implant System in a patient. Consist of instruments: Clamp head Clamp head Pusher Clamp head Screw Pressure Peg Hex T-Handle 5 mm Spanner 14 mm Spanner 12 mm Spanner 10 mm
Integrum AB
2531
In Commercial Distribution

  • 07340152101976 ()


  • Internal-external leg prosthesis osseointegration bar
Audio Processor Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
34429
In Commercial Distribution

  • 09008737344290 ()


  • Hearing aid/implant system remote control
Audio Processor Remote Control and Battery
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
37342
In Commercial Distribution

  • 09008737373429 ()


  • Hearing aid/implant system remote control
Audio Processor Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
41218
In Commercial Distribution

  • 09008737412180 ()


  • Hearing aid/implant system remote control
The Praxis™ Extended RAS Panel assay is designed specifically for the detection of 56 mutations from exons 2, 3, and 4 of the KRAS and NRAS genes using the Illumina MiSeqDx Instrument. The assay has been configured for 2 runs with a maximum of 10 samples plus 2 controls per run. Illumina provides the following reagents for the Illumina Praxis Extended RAS Panel: 20012195, Praxis Extended RAS Panel – 1/6; 20012196, Praxis Extended RAS Panel – 1A; 20012197, Praxis Extended RAS Panel – 1B; 20012198, Praxis Extended RAS Panel – 2/6; 20012199, Praxis Extended RAS Panel – 3/6; 20012200, Praxis Extended RAS Panel – 3A; 20012201, Praxis Extended RAS Panel – 3B; 20012202, Praxis Extended RAS Panel – 4/6; 20012203, Praxis Extended RAS Panel – 5/6; and 20012204, Praxis Extended RAS Panel – 6/6.
ILLUMINA, INC.
20012431
Not in Commercial Distribution

  • 00816270020088 ()
20012431

  • Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
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