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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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MEGAPULSE 15+ - 04055207053980

LASER FIBER Ø 230µM DISPOSABLE Core Diameter 230µm, PACK=5 PCS, sterile, for single use
Richard Wolf GmbH
487501235
Not in Commercial Distribution

  • 04055207053980 ()
  • 04055207053997 ()

  • Outer Diameter: 230 Micrometer
487501235

  • Laser lithotripsy system

DIALFIX 15 - 08800125000037

No Description
DFIX
01
In Commercial Distribution

  • 08800125000037 ()

  • Wound size 15 to 20cm


  • Skin-closing tension device

StoneLight 15 - 00859932006013

Ho:YAG Laser System
NEW STAR LASERS, INC.
7300-0028
Not in Commercial Distribution

  • 00859932006013 ()
NS1800

  • General/multiple surgical solid-state laser system

CORVUS 15 - 00852656007502

CORVUS 15 is intended for use as a planning tool for conformal radiation therapy. The CORVUS system is intended to be used as an integrated system with a delivery device for planning and delivery of conformal radiation therapy. . For IMRT, using operator-supplied input and patient scans, it creates a plan for treatment delivery systems and generates a set of beam weights that, when applied to a compatible system, facilitates delivery of an intensity-modulated 3D conformal radiation therapy treatment. For Forward Planning, CORVUS helps the user manually create a plan for treatment delivery based on user supplied inputs and patient scans including dose calculation. Forward Planning is supported only for Cobalt-60 based treatment planning.
Best Nomos
210764
In Commercial Distribution

  • 00852656007502 ()


  • Radiation therapy software

ACCESS 15 - 03596010441522

REMOTE CONTROL ACCESS 15 PUMP
Smith & Nephew, Inc.
7205797
In Commercial Distribution

  • 03596010441522 ()
7205797

  • Endoscopic device remote control

Capricorn 15 - D7075840580

No Description
IVOCLAR VIVADENT, INC.
584058
Not in Commercial Distribution

  • D7075840580 ()
584058

  • Dental casting noble alloy

FLXfit 15 - M725AT40130

FLXfit 15 Expandable Interbody
CORELINK LLC
AT4013
In Commercial Distribution

  • M725AT40130 ()


  • Metallic spinal interbody fusion cage

FLXfit 15 - M725AT40120

FLXfit 15 Expandable Interbody
CORELINK LLC
AT4012
In Commercial Distribution

  • M725AT40120 ()


  • Metallic spinal interbody fusion cage

FLXfit 15 - M725AT40110

FLXfit 15 Expandable Interbody
CORELINK LLC
AT4011
In Commercial Distribution

  • M725AT40110 ()


  • Metallic spinal interbody fusion cage

FLXfit 15 - M725AT40100

FLXfit 15 Expandable Interbody
CORELINK LLC
AT4010
In Commercial Distribution

  • M725AT40100 ()


  • Metallic spinal interbody fusion cage
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