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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
Change Healthcare Canada Company
1.0.3
Not in Commercial Distribution

  • 17540262130041 ()


  • Radiological PACS software
No Description
Change Healthcare Canada Company
1.0.1
Not in Commercial Distribution

  • 17540262130027 ()


  • Radiological PACS software
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 rechargeable, multi-use, adhesive patches that record physiological parameters during sleep. The kit is coupled with a charging pad for recharging, and 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.
Tatch Inc.
WSWW-RE-K-N-V01-GRD
In Commercial Distribution

  • 00860007837012 ()


  • Polysomnograph
The Huma platform is a modular Software as a Medical Device (SaMD) which may utilise compatible devices and software to obtain data collated via a mobile app or web app and delivered to the clinician via a web portal or web app where it may be viewed to drive clinical management. It is intended to be used for the physiological and non-physiological intermittent or spot-check monitoring of all condition patients in professional healthcare facilities, such as clinics, hospitals or skilled nursing facilities, or in the patient’s home setting. It is intended for the monitoring of patients by trained healthcare professionals. The Huma platform comprises a number of different modules and functionalities that can be selected by the customer for configuration of care plans which can be further personalised for the patients. Clinical information collected from these modules is displayed on a clinician web portal and patient app with the addition of flagging out of range datasets, trend visualisation, goal setting and communication channels between clinicians and patients.
MedoPad Inc.
1.34
In Commercial Distribution

  • G2871002 ()
1002

  • Self-care monitoring/reporting software
No Description
WITTENSTEIN intens GmbH
ME Tray TAA09/11 loan
Not in Commercial Distribution

  • 04260170143570 ()
60002062

  • General internal orthopaedic fixation system implantation kit
Thermidas VistaClinic Analyzer is a software app for the analysis of images that have been captured with Thermidas IRT-384 Tablet. The tools include adjustment of color scale, use of regions of interest, zoom & pan, and annotations.
TherMidas Oy
Thermidas VistaClinic Analyzer
In Commercial Distribution

  • 06429810718044 ()
ThAnalyzer

  • Infrared thermography system
LEGGINGS MAMAN 70 OPAQUE, SIZE M, MOKA, GRADUATED COMPRESSION 12/15 mmHg OPAQUE LEGGINGS FOR EXPECTANT MOhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#THERS WITH A POUCH AND A SUPPORTING BAND SUITABLE FOR THE GROWING BELLY
CALZIFICIO PINELLI SRL
057611
In Commercial Distribution

  • 08300496057611 ()
048670

  • Compression/pressure tubular garment
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
"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth." https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
DiaDent Group International
ISO 45
In Commercial Distribution

  • 08806383528894 ()
MP201-309

  • Endodontic paper point
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