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
NT-Trading GmbH & Co. KG
UTG-2CON 80334A3M
Not in Commercial Distribution

  • ENTTUTG2CON80334A3M1 ()

  • 2-CONnect®-Abutment Ø 3,3 - 4,25 mm; gingiva height 2,5 mm; angled 20°;Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 80334A3M

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
Calibra® Esthetic Resin Cement Veneer Kit
DENTSPLY INTERNATIONAL INC.
607200
Not in Commercial Distribution

  • D0026072001 ()

  • Weight: 2 Gram
  • 5 Syringes Cement, 5 Syringes Try-In Paste, 1 Bottle Adhesive, 1 Dispensing Well, 50 Tips, 1 Light Protection Cover, 1 Syringe Silane Coupling Agent, 1 Syringe Tooth Cond Gel, 25 App Needles
  • Weight: 1.8 Gram
607200

  • Dental composite resin
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 80334A3S
Not in Commercial Distribution

  • ENTTUTG2CON80334A3S1 ()

  • 2-CONnect®-Abutment Set Ø 3,3 - 4,25 mm; gingiva height 2,5 mm; angled 20°; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 80334A3S

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
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
TPH®3 Easy-Twist Syringe Introductory Kit
DENTSPLY INTERNATIONAL INC.
642706
Not in Commercial Distribution

  • D0026427061 ()

  • Weight: 3 Gram
  • Total Volume: 3 Milliliter
  • 8 TPH3 Syringes, 5 P&B Unit Doses, 1 Prisma Gloss Fine and Extrafine Syringe, 1 syringe Tooth Cond Gel, 1 shade guide, 25 polishing cups, 1 mandrel, Enhance Discs, Cups, & Points, 5 App Tips
642706

  • Dental composite resin
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
ENHANCED ALGORITHM ECG EVENT RECORDER
BRAEMAR MANUFACTURING, LLC
900-0557-06
In Commercial Distribution

  • B146ER9R0 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&

  • Electrocardiography telemetric monitoring system
The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG management solution. (Medical Device Data System) The light weight and portable Spaulding Electrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph) information to the WebECG system and receives a report back from the WebECG system. The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ or Windows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable and strategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a 12-lead ECG.
SPAULDING MEDICAL
2100iQ
In Commercial Distribution

  • B441IQ0 ()


  • Electrocardiograph, professional, multichannel
The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG management solution. (Medical Device Data System) The light weight and portable Spaulding Electrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph) information to the WebECG system and receives a report back from the WebECG system. The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ or Windows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable and strategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a 12-lead ECG.
SPAULDING MEDICAL
2100iQ
In Commercial Distribution

  • B441BTIEC0 ()


  • Electrocardiograph, professional, multichannel
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