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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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OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-D
In Commercial Distribution

  • 05060396173714 ()


  • Otoacoustic emission system, battery-powered
OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-DT
In Commercial Distribution

  • 05060396173486 ()


  • Otoacoustic emission system, battery-powered
UNIVERSAL CATHETERIZATION TRAY. CONTENTS: DRAINAGE BAG 2000 CC, SYRINGE 10 CC PRE-FILLED WITH STERILE WATER, VINYL GLOVES (1 PAIR), DRAPE, FENESTRATED DRAPE, CATHETER LUBRICATING JELLY, SPECIMEN CONTAINER 2oz, PATIENT LABEL, WRAP, PVP SWAB STICKS (3).
GHC HEALTHCARE, INC.
60-T02
In Commercial Distribution

  • 40872237001802 ()
  • 00872237001804 ()


  • Urethral catheterization support kit, urinary drainage
HYDROGEL COATED LATEX FOLEY CATHETER, COUDE TIP, 5 CC, 2-WAY, 24 FR (8.0 MM), AMBER LATEX
Cardinal Health 200, LLC
1624C
In Commercial Distribution

  • 50192253027561 ()
  • 20192253027560 ()
  • 10192253027563 ()
1624C

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
HYDROGEL COATED LATEX FOLEY CATHETER, COUDE TIP, 5 CC, 2-WAY, 22 FR (7.3 MM), AMBER LATEX
Cardinal Health 200, LLC
1622C
In Commercial Distribution

  • 20192253027553 ()
  • 10192253027556 ()
  • 50192253027554 ()
1622C

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
HYDROGEL COATED LATEX FOLEY CATHETER, COUDE TIP, 5 CC, 2-WAY, 20 FR (6.7 MM), AMBER LATEX
Cardinal Health 200, LLC
1620C
In Commercial Distribution

  • 50192253027547 ()
  • 20192253027546 ()
  • 10192253027549 ()
1620C

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
HYDROGEL COATED LATEX FOLEY CATHETER, COUDE TIP, 5 CC, 2-WAY, 18 FR (6.0 MM), AMBER LATEX
Cardinal Health 200, LLC
1618C
In Commercial Distribution

  • 50192253027523 ()
  • 20192253027522 ()
  • 10192253027525 ()
1618C

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
HYDROGEL COATED LATEX FOLEY CATHETER, COUDE TIP, 5 CC, 2-WAY, 16 FR (5.3 MM), AMBER LATEX
Cardinal Health 200, LLC
1616C
In Commercial Distribution

  • 20192253027515 ()
  • 10192253027518 ()
  • 50192253027516 ()
1616C

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
HYDROGEL COATED LATEX FOLEY CATHETER, COUDE TIP, 5 CC, 2-WAY, 14 FR (4.7 MM), AMBER LATEX
Cardinal Health 200, LLC
1614C
In Commercial Distribution

  • 20192253027508 ()
  • 10192253027501 ()
  • 50192253027509 ()
1614C

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
HYDROGEL COATED LATEX FOLEY CATHETER, COUDE TIP, 5 CC, 2-WAY, 12 FR (4.0 MM), AMBER LATEX
Cardinal Health 200, LLC
1612C
In Commercial Distribution

  • 20192253027492 ()
  • 10192253027495 ()
  • 50192253027493 ()
1612C

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
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