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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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Rotational Excisional Atherectomy System. The Catheter Set includes one Rotarex®S catheter (gauge 6F; length 135 cm), one guidewire (0.018” diameter; 320 cm in length), one drape and one collecting bag.
Straub Medical AG
Version 1.0
Not in Commercial Distribution

  • 07640142810582 ()

  • Catheter Working Length: 135 Centimeter
  • Catheter Gauge: 6 French
80237

  • Mechanical atherectomy system catheter/handpiece
VS BRST 1.5T 8CH TT FUL SET w ESPREE RSR consists of one patient support assembly, one medial coil element, one interface box, 1Ch left and right coil elements, one medial plug, 3Ch left and right coil elements, one fiducial marker block assembly, and one box of 10 sterilized biopsy grids.
Philips Medical Systems Nederland B.V.
989603217331
In Commercial Distribution

  • 00884838120051 ()


  • MRI system coil, radio-frequency
VS BRST 1.5T 8CH TT FUL SET w SHALOW RSR consists of one patient support assembly, one medial coil element, one interface box, 1Ch left and right coil elements, one medial plug, 3Ch left and right coil elements, one fiducial marker block assembly and one box of 10 sterilized biopsy grids.
Philips Medical Systems Nederland B.V.
989603217341
In Commercial Distribution

  • 00884838120020 ()


  • MRI system coil, radio-frequency
VS BREAST 1.5T 16CH TT FULL SET consists of one patient support assembly, one fiducial marker block assembly, one box of 10 sterilized biopsy grids, 4Ch left and right coil elements, one 8Ch medial coil element, one 16Ch interface box, 1Ch left and right coil elements, and one medial plug.
Philips Medical Systems Nederland B.V.
989603217571
In Commercial Distribution

  • 00884838119895 ()


  • MRI system coil, radio-frequency
Plaster spreader for one hand, 9"
BR Surgical, LLC
WG30-36623
In Commercial Distribution

  • 00840183517687 ()
WG30-36623

  • Cast spreader, reusable
TAUT SYSTEM ONE TRIFECTA BALLOON 5FRX75
TELEFLEX INCORPORATED
IPN007865
In Commercial Distribution

  • 24026704418910 ()

  • Length: 86.5 Centimeter
50640

  • Laparoscopic access cannula, single-use
Nyström, one pair, I and II
E. Hahnenkratt GmbH
20
In Commercial Distribution

  • E206200 ()


  • Dental matrix band tensioner
BIO | One Stage Implant Driver Long
BLUE SKY BIO LLC
DT0018
In Commercial Distribution

  • 00810060221419 ()


  • Surgical torque wrench adaptor
BIO | One Stage Implant Driver Short
BLUE SKY BIO LLC
DT0014
In Commercial Distribution

  • 00810060221402 ()


  • Surgical torque wrench adaptor
BIO | One Stage Digital Scan Body
BLUE SKY BIO LLC
MOD5500
In Commercial Distribution

  • 00810060224939 ()


  • Dental implant analog
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