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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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SURETAC III 0 DEGREE STER OVAL HEAD
Smith & Nephew, Inc.
7209900
Not in Commercial Distribution

  • 03596010480798 ()
7209900

  • Meniscus knife
T-Shape, Swivel Oxygen Port; Adult : Tidal Volume Range(75-1500mL), Media(Corrugated Paper), Dead Space(15mL), Breathing Resistance(0.15cm H2O at 30L/min), Weight(7.8g)
Dynarex Corporation
30303
In Commercial Distribution

  • 00840117318106 ()
  • 00840117318113 ()


  • Heat/moisture exchanger, single-use
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™ 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™ 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
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
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
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
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
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
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