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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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SeeMore Software 2.0.03 Generic
INTERSON CORP
2.0.03 GEN
In Commercial Distribution

  • 00850921007103 ()
98-3517-00

  • Extracorporeal ultrasound imaging transducer, hand-held
SeeMore Software 2.0.03 Urology
INTERSON CORP
2.0.03 URO
In Commercial Distribution

  • 00850921007066 ()
98-3517-02

  • Extracorporeal ultrasound imaging transducer, hand-held
Software used for the interaction and programming of the Novi Device.
SCOTTCARE CORPORATION, THE
Novi Software
In Commercial Distribution

  • 00856298006237 ()
101633

  • Electrocardiographic long-term ambulatory recording analyser application software
Software used for interaction and programming of the TeleSenseRCM and TeleSense-E devices.
SCOTTCARE CORPORATION, THE
TeleSense Software
In Commercial Distribution

  • 00856298006213 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Supplemental Software provided on a thumb drive. Enables programming of the electrical stimulation parameters of the implant.
Second Sight Medical Products, Inc.
014300-000
Not in Commercial Distribution

  • 00856264005776 ()
014300

  • Retinal prosthesis system tester/clinical evaluator
The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles by preserving hair integrity (amount of hair per follicle and hair quality) for further hair graft implantation. This is done by optimizing hair transplant for both the receiver (increasing quality of the recipient area with respect to naturalness and density) and the donor (taking care of the donor region). The WAW Duo FUE System is composed of the following: - The WAW Wireless Handpiece: o Composed of a motor and a battery, and a detachable cleanable (via autoclave) external sleeve o Connected via Bluetooth to the tablet o Responsible for the rotation and oscillation movements of the punch (not included) for the FUE, - The WAW Wired Handpiece, a backup solution for the WAW Wireless Handpiece: o Cleanable (via autoclave) o Connected via a wire to the pedal o Responsible for the rotation and oscillation movements of the punch for the FUE, - The WAW Pedal, responsible for activating the handpieces, - The WAW Software, responsible for defining the parameters of functioning (rotation and oscillation movement) of the handpieces and mode (manual, semi-auto, auto or continuous) of the pedal (the Samsung tablet is supplied), - The WAW Charging Station, intended to recharge the wireless handpiece and - The External Sleeve Support Box, intended to sustain external parts of WAW Wireless Handpiece and WAW Wired Handpiece during autoclave process. - Assembly tools: 3 mounting tools to assemble and disassemble the handpieces.
Devroye Instruments Belgium
0.1.35
In Commercial Distribution

  • 05430003362068 ()


  • Electrosurgical handpiece, reusable
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M815000
In Commercial Distribution

  • 00817020020884 ()


  • Visual-reinforcement audiometer
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M817000
In Commercial Distribution

  • 00817020020877 ()


  • Tone audiometer
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M814000
In Commercial Distribution

  • 00817020020860 ()


  • Bioelectrical signal analysis software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M813000
In Commercial Distribution

  • 00817020020853 ()


  • Bioelectrical signal analysis software
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