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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 Cassi Rotational Core Biopsy System is used to perform biopsy procedures on multiple patients. Up to 7 biopsy cycles (1 mandatory pre-testand 6 biopsies) can be performed per patient. The Cassi system components and catalog numbers are: REF: CS2100-NT Cassi Rotational Core Biopsy Needle – 10 gauge 10 – Sterile single-use biopsy needles and sample trays; comprised of a 19 gauge x 2 cm length securing needle with 10 gauge cutting cannula with trocar REF: CS2120-NT Cassi Rotational Core Biopsy Needle – 12 gauge 10 – Sterile single-use biopsy needles and sample trays; comprised of a 19 gauge x 2 cm length securing needle with a 12 gauge cutting cannula with trocar REF: CS2001-CC-10 10 – Non-sterile single-use CO2 (carbon dioxide) canisters with caps REF:CS2001-BH 1 – Non-sterile limited reusable biopsy handle and 1 spare limited-use 9 – volt alkaline battery
SCION MEDICAL TECHOLOGIES, LLC
CS2100-NT-1
In Commercial Distribution

  • 10866479000128 ()
  • 00866479000121 ()


  • Soft-tissue biopsy needle, single-use
Large fragment plate, 9 hole, 205 mm
Incipio Devices
00-505-050-09
Not in Commercial Distribution

  • 00866204000211 ()


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
A digital thermometer designed to measure body temperature orally, rectally or under the arm. It has a silicon & plastic structure, a metal sensing tip and a battery-powered chip and LCD screen. It is for multiple uses.
GMB INTERNATIONAL LIMITED
001
Not in Commercial Distribution

  • 00866066000305 ()


  • Thermometer kit
No Description
SURGISTAR, INC.
8192
In Commercial Distribution

  • 10878799002874 ()
  • 00878799002877 ()


  • Cotton pledget applicator, single-use
No Description
SURGISTAR, INC.
8191
In Commercial Distribution

  • 10878799002867 ()
  • 00878799002860 ()


  • Cotton pledget applicator, single-use
Activac Therapy System
KCI USA, INC.
340000
In Commercial Distribution

  • 00878237008188 ()
  • 00878237001813 ()


  • Negative-pressure wound therapy system, battery-powered, reusable
No Description
Inmedico A/S
USB350-SP
Not in Commercial Distribution

  • 05713557000120 ()


  • Speech audiometer
  • Tone audiometer, manual
  • Tone audiometer, automated
  • Tone audiometer
No Description
Inmedico A/S
USB350-B
Not in Commercial Distribution

  • 05713557000113 ()


  • Tone audiometer, manual
  • Tone audiometer, automated
  • Tone audiometer
No Description
Inmedico A/S
USB330
Not in Commercial Distribution

  • 05713557000106 ()


  • Tone audiometer, manual
  • Tone audiometer, automated
  • Tone audiometer
No Description
Inmedico A/S
USB310
Not in Commercial Distribution

  • 05713557000090 ()


  • Tone audiometer, automated
  • Tone audiometer, manual
  • Tone audiometer
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