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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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No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11298564
In Commercial Distribution

  • 04056869147918 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11298563
In Commercial Distribution

  • 04056869147901 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11298562
In Commercial Distribution

  • 04056869147895 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11298561
In Commercial Distribution

  • 04056869147888 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
VA3
In Commercial Distribution

  • 04068151027013 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11589501
In Commercial Distribution

  • 04068151009477 ()


  • PET system application software
  • SPECT system application software
The device is a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall which is non-powered, hand-held, and hand-manipulated, intended to be used in various general surgical procedures. The device includes a ligature carrier pathway, needle guide, two needles, reference plane T-Bar, and a guidewire. The handle of the device provides two diametrically opposed enclosed guideways for the advancement and retraction of the needles under manual control of a plunger located at the proximal end of the device. As part of the M-Close convenience kit, a Nerve Block Needle is included for the administration of local anesthetic agents to provide regional and local anesthesia. A Telfa Antimicrobial, non-Adherent Pad is provided in the kit for use as a primary dressing for the surgical incision as well as a slip-tip syringe.
New Wave Endo-Surgery Inc.
27-108
In Commercial Distribution

  • 00850009417220 ()
  • 00850009417213 ()
  • 00850009417237 ()
  • 00850009417244 ()

  • Outer Diameter: 12 Millimeter
27-108

  • Suturing unit, single-use
The device is a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall which is non-powered, hand-held, and hand-manipulated, intended to be used in various general surgical procedures. The device includes a ligature carrier pathway, needle guide, two needles, reference plane T-Bar, and a guidewire. The handle of the device provides two diametrically opposed enclosed guideways for the advancement and retraction of the needles under manual control of a plunger located at the proximal end of the device.As part of the M-Close convenience kit, a Nerve Block Needle is included for the administration of local anesthetic agents to provide regional and local anesthesia. A Telfa Antimicrobial, non-Adherent Pad is also provided in the kit for use as a primary dressing for the surgical incision.
New Wave Endo-Surgery Inc.
27-101
In Commercial Distribution

  • 00850009417053 ()
  • 00850009417022 ()
  • 00850009417060 ()
  • 00850009417107 ()

  • Outer Diameter: 12 Millimeter
27-101

  • Suturing unit, single-use
Therapeutic massager to internally massage trigger points in the pelvic floor musculature.
NEW PELVIC PAIN TECHNOLOGIES
1112
In Commercial Distribution

  • 00862945000404 ()


  • Pelvic floor internal manual massager
Disposable Orthodontic Archwire White Markers
New Venture Enterprise Ltd.
WWS
In Commercial Distribution

  • 20860012076615 ()
  • 00860012076611 ()
  • 10860012076618 ()


  • Orthodontic archwire
Disposable Orthodontic Archwire Orange Markers
New Venture Enterprise Ltd.
OWS
In Commercial Distribution

  • 10860012076601 ()
  • 00860012076604 ()
  • 20860012076608 ()


  • Orthodontic archwire
Fiber Optic Catheter
NEW STAR LASERS, INC.
7420-0021
Not in Commercial Distribution

  • 00859932006099 ()


  • General/multiple surgical solid-state laser system
Fiber Optic Catheter
NEW STAR LASERS, INC.
7420-0025
Not in Commercial Distribution

  • 00859932006105 ()


  • General/multiple surgical solid-state laser system
Fiber Optic Catheter
NEW STAR LASERS, INC.
7420-0019
Not in Commercial Distribution

  • 00859932006082 ()


  • General/multiple surgical solid-state laser system
Fiber Optic Catheter
NEW STAR LASERS, INC.
7420-0087
Not in Commercial Distribution

  • 00859932006075 ()


  • General/multiple surgical solid-state laser system
Fiber Optic Catheter
NEW STAR LASERS, INC.
7420-0023
Not in Commercial Distribution

  • 00859932006068 ()


  • General/multiple surgical solid-state laser system
Fiber Optic Catheter
NEW STAR LASERS, INC.
7420-0023M
Not in Commercial Distribution

  • 00859932006051 ()


  • General/multiple surgical solid-state laser system
Nd:YAG Laser System
NEW STAR LASERS, INC.
R7300-0042
Not in Commercial Distribution

  • 00859932006044 ()
NS160

  • General/multiple surgical solid-state laser system
Nd:YAG Laser System
NEW STAR LASERS, INC.
R7300-0055
Not in Commercial Distribution

  • 00859932006037 ()
LC225

  • General/multiple surgical solid-state laser system
Nd:YAG Laser System
NEW STAR LASERS, INC.
R7300-0058
Not in Commercial Distribution

  • 00859932006020 ()
NS160

  • General/multiple surgical solid-state laser system
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