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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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Medtronic Reusable Instrument - 00721902730399

INSTRUMENT 874-447 ML 9X11MMDP CTTR 7MM
MEDTRONIC SOFAMOR DANEK, INC.
874-447
In Commercial Distribution

  • 00721902730399 ()


  • Orthopaedic knife

Medtronic Reusable Instrument - 00721902730351

INSTRUMENT 874-445 ML 9X11MMDP CTTR 5MM
MEDTRONIC SOFAMOR DANEK, INC.
874-445
In Commercial Distribution

  • 00721902730351 ()


  • Orthopaedic knife

Copioumed - 04719882250897

Copioumed's surgical drape can effectively block the penetration of bodily fluids during surgery, prevent cross-infection, and maintain a sterile field at the surgical site.
COPIOUMED INTERNATIONAL INC.
SDS0B101-1
In Commercial Distribution

  • 04719882250897 ()
  • 14719882250894 ()


  • Patient surgical drape, single-use

CORTAC® - 00650551056300

SUBDURAL GRID ELECTRODE, PLATINUM, 64 CONTACT, 8X8, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 4 EXITS, 4 LEADS, 4 TAILS, ALL CONTACTS NUMBERED
PMT CORPORATION
2110TX-64-061
In Commercial Distribution

  • 00650551056300 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2110TX-64-061

  • Cortical electrode

CORTAC® - 00650551056294

SUBDURAL GRID ELECTRODE, PLATINUM, 64 CONTACT, 8X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 4 EXITS, 4 LEADS, 4 TAILS, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-64-061
In Commercial Distribution

  • 00650551056294 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2110-64-061

  • Cortical electrode

CORTAC® - 00650551051312

SUBDURAL GRID ELECTRODE, PLATINUM, 16 CONTACT TAIL WITH #5 DEAD, 4X4, RADIOPAQUE MARKER AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-15-010
In Commercial Distribution

  • 00650551051312 ()

  • Thickness 1.01 Millimeter
  • Contact Diameter 2 & 3 Millimeter
2110-15-010

  • Cortical electrode

Mendec V FILL - 08031497001456

The device is an accessory intended to fill up to six needles or fillers with acrylic resins for vertebroplasty/kyphoplasty at the same time.
TECRES SPA
ASC0000
In Commercial Distribution

  • 08031497001456 ()


  • Orthopaedic cement preparation/delivery kit

PCRopsis - B5507837810000

PCRopsis™ Reagent RVD-RT (1000 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.
ENTOPSIS, LLC
Reagent RVD-RT
Not in Commercial Distribution

  • B5507837810000 ()
783781000

  • Nucleic acid extraction/isolation kit IVD

PCRopsis - B550783781000

PCRopsis™ Reagent RVD-RT (100 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.
ENTOPSIS, LLC
Reagent RVD-RT
Not in Commercial Distribution

  • B550783781000 ()
78378100

  • Nucleic acid extraction/isolation kit IVD

PCRopsis - B550783780250

PCRopsis™ Reagent RVD-RT (25 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.
ENTOPSIS, LLC
Reagent RVD-RT
Not in Commercial Distribution

  • B550783780250 ()
78378025

  • Nucleic acid extraction/isolation kit IVD
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