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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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CPC-Base with base Plate - 04251269201516

No Description
Noras MRI products GmbH
13
In Commercial Distribution

  • 04251269201516 ()
113120

  • MRI system coil, radio-frequency

AuDX Device with touchscreen - 04260223143281

AuDX branded Sentiero
PATH medical GmbH
100098-AU
In Commercial Distribution

  • 04260223143281 ()


  • Evoked-potential audiometer

coflex-F Handle with ratchet - 04260148897689

No Description
Paradigm Spine GmbH
RAT20500
In Commercial Distribution

  • 04260148897689 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Simplex HV with Gentamicin - 04260056885761

Simplex® HV with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. Simplex® HV with Gentamicinn cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. Simplex® HV with Gentamicin does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
OSARTIS GmbH
6195-1-001
In Commercial Distribution

  • 24260056885765 ()
  • 14260056885768 ()
  • 04260056885761 ()

  • Total Volume: 20 Milliliter
  • Weight: 40.8 Gram
6195-1-010

  • Orthopaedic cement, antimicrobial

PLASTIC WEDGES WITH HOLE - D89260705415271

No Description
MAXILL, INC.
6070541527
In Commercial Distribution

  • D89260705415270 ()
  • D89260705415271 ()


  • Dental wedge, single-use

PLASTIC WEDGES WITH HOLE - D89260705415281

No Description
MAXILL, INC.
6070541528
In Commercial Distribution

  • D89260705415280 ()
  • D89260705415281 ()


  • Dental wedge, single-use

PLASTIC WEDGES WITH HOLE - D89260705415261

No Description
MAXILL, INC.
6070541526
In Commercial Distribution

  • D89260705415260 ()
  • D89260705415261 ()


  • Dental wedge, single-use

Trinity with XL Heads - 05055196937956

Trinity CoCrMo Modular Head 40mm EXTRA LONG +8.0mm 12/14 Eurocone Taper
CORIN LTD
E321.340
In Commercial Distribution

  • 05055196937956 ()
E321.340

  • Metallic femoral head prosthesis

Trinity with XL Heads - 05055196937918

Trinity CoCrMo Modular Head 36mm EXTRA LONG +8.0mm 12/14 Eurocone Taper
CORIN LTD
E321.336
In Commercial Distribution

  • 05055196937918 ()
E321.336

  • Metallic femoral head prosthesis

Trinity with XL Heads - 05055196937123

Trinity CoCr Modular Head Ø32mm EXTRA LONG +7.0mm 12/14 Eurocone Taper
CORIN LTD
E321.332
In Commercial Distribution

  • 05055196937123 ()
E321.332

  • Metallic femoral head prosthesis
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