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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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Option to the MAMMOMAT Inspiration FFDM system to acquire tomosynthesis images for mammography
Siemens Healthcare GmbH
11104944
In Commercial Distribution

  • 04056869001005 ()


  • Stationary mammographic x-ray system, digital
The Macy Catheter is intended to provide rectal access to administer liquids/medications.
HOSPI CORPORATION
E
In Commercial Distribution

  • 00861003000202 ()
MAC-1001

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Cylindrical tip dedicated to drill and widen the access canal to schneiderian membrane
SATELEC
TIP TKW3 II
In Commercial Distribution

  • 03609820875330 ()
F87533

  • Dental ultrasonic surgical system handpiece tip
Cylindrical tip dedicated to drill and widen the access canal to schneiderian membrane
SATELEC
TIP TKW3
In Commercial Distribution

  • 03609820873336 ()
F87333

  • Dental ultrasonic surgical system handpiece tip
Gold Lens (Pediatric): A non-sterile corneal electrode intended to be applied to the eye to detect the electrical response of the retina after a photic or other stimulus. It is typically in the form of a silver or gold electrode applied to the surface of the eye on or near the cornea. The general device that records this electrical activity is the electroretinograph (ERG).
DIAGNOSYS LLC
D102
In Commercial Distribution

  • 00855730007337 ()
D102

  • Electroretinograph electrode
Gold Lens (Adult): A non-sterile corneal electrode intended to be applied to the eye to detect the electrical response of the retina after a photic or other stimulus. It is typically in the form of a silver or gold electrode applied to the surface of the eye on or near the cornea. The general device that records this electrical activity is the electroretinograph (ERG).
DIAGNOSYS LLC
D101
In Commercial Distribution

  • 00855730007320 ()
D101

  • Electroretinograph electrode
The Endoscope tracker EM provides a way to track the location of compatible conventional rigid endoscopes. The location of the instrument is referenced relative to a patient tracker. The Endoscope tracker EM connects to the Hybrid Navigation Unit EM via an integrated cable. The Endoscope tracker EM is provided non-sterile and is intended to be sterilized by the user. The Endoscope tracker EM is reusable.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U1037020 ()
U1 037 02

  • Electromagnetic surgical navigation device tracking system
The Uterine Sound is used to gauge the depth and position of the uterine cavity. It is also helpful with the placement of IUDs and the verification of the intrauterine position and length for HSG procedures. The proximal portion of the sound is 3.5 mm in diameter tapering to 2.5 mm at the distal portion with a bulbous tip to reduce the risk of perforation. Malleable to adapt to anatomical variations.It is a sterile, disposable, single-use only device.
PANPAC MEDICAL CORPORATION
BA100
In Commercial Distribution

  • 04715309122037 ()
  • 04715309125250 ()


  • Uterine sound, single-use
The Monopolar Hook is a single-use sterile electrosurgical electrode for use with the HandXTM device. The Monopolar Hook is connected to the HandX device and transmits the HandX device motors’ rotation in order to articulate the movement of the end effector of the Monopolar Hook. It is designed to address surgeons’ needs relating to the application of monopolar diathermy for various surgical purposes. The Monopolar Hook is connected to a standard electrosurgical unit via a standard generator cable.
HUMAN XTENSIONS LTD
20-30-044-01
In Commercial Distribution

  • 07290017376080 ()
  • 17290017376087 ()
20-30-073-01

  • Endoscopic electrosurgical electrode, monopolar, single-use
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
AS-NGMM1610POS
In Commercial Distribution

  • 05712821010513 ()
AS-NGMM1610POS

  • Dental prosthesis/implant abutment screw
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