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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Cylindrical Implant - 3.75 X Length 11.5mm Regular 2.42 Internal Hex
BHI IMPLANTS LTD
1
In Commercial Distribution

  • 07290109745893 ()

  • Outer Diameter: 3.75 Millimeter
  • Length: 11.5 Millimeter
D-DFhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#3711

  • Basket endosteal dental implant, two-piece
Esthet-X® HD High Definition Micro Matrix Restorative Total-Etch Direct Restorative Kit
DENTSPLY INTERNATIONAL INC.
630607
Not in Commercial Distribution

  • D0026306071 ()

  • Weight: 0.25 Gram
  • 6 Compules® Tips, 1 Compules® Tips Gun, 3 Compula® Tips, Enhance® Finishers, 6 Bond Unit Doses, 1 Unit Dose Holder, 6 Flocked Applicator Tips, 1 Syringe Tooth Cond Gel, 25 App Tips
  • Total Volume: 3 Milliliter
630607

  • Dental composite resin
FluoroCore® 2+ Dual Cure Core Build-Up Material + Fast Endodontic Post Cement Introductory Kit
DENTSPLY INTERNATIONAL INC.
612400
Not in Commercial Distribution

  • D0026124001 ()

  • Weight: 4.75 Gram
  • 2 Tooth Colored Syringes, 2 Blue Syringes, 1 bottle each Xeno®, P&B, and activator, 25 Mixing Tips, 25 Intraoral Tips, 10 Endo Intaoral Tips, 1 Disp Well, 50 App Tips, 50 Root Canal Tips
612400

  • Dental composite resin
Handheld (Bluetooth Low Energy protocol) personal wireless microphone to help hear companions easier in noisy or challenging listening environments. Used with RX8 Hearing aid(s) and controlled with RxEars APP as well as controls on the unit itself.
Persona Medical
Remote Microphone Wireless Streamer
In Commercial Distribution

  • 00851362008063 ()


  • Air-conduction hearing aid, behind-the-ear
Handheld (Bluetooth Low Energy protocol) personal wireless microphone to help hear companions easier in noisy or challenging listening environments. Used with Evok 1600 Hearing aid(s) and controlled with Persona APP as well as controls on the unit itself.
Persona Medical
Remote Microphone Wireless Streamer
In Commercial Distribution

  • 00851362008131 ()


  • Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
Sombra XS
In Commercial Distribution

  • 00851362008124 ()


  • Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
Sombra VS
In Commercial Distribution

  • 00851362008117 ()


  • Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
Sombra XR
In Commercial Distribution

  • 00851362008100 ()


  • Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
Sombra VR
In Commercial Distribution

  • 00851362008094 ()


  • Air-conduction hearing aid, behind-the-ear
Wesper Lab (“the device”) is a digital recording device designed to collect sleep data in adult patients as prescribed by a healthcare professional. Wesper Lab uses a set of multi-use, adhesive patches that record physiological parameters during sleep. The kit is coupled with a pulse oximeter to collect information about pulse rate and oxygen desaturations. The device employs a mobile application (“the app”), which resides on the patient’s personal mobile device, relaying sleep data wirelessly to a secure remote storage location (“the cloud”) for subsequent analysis by a healthcare professional. The app has 3 Bluetooth Low-Energy (BLE) ports, each of which receives multiple physiological channels from the patient. The device’s BLE ports connect to the following: 1. Abdominal patch 2. Thoracic patch 3. Pulse oximeter Data from the patches are transmitted via BLE throughout the night to the app, which uploads the data to the cloud. The third BLE port on the app connects to an authorized FDA-cleared pulse oximeter. This Device Identification is for a kit that is shipped without a charger.
Tatch Inc.
WSWW-RE-K-N-V02-BLO
In Commercial Distribution

  • 00860007837029 ()


  • Polysomnograph
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