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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Compatible with Dentsply Sirona XiVE MP _ TG Set consisting of: 1x Impression coping NON HEX 1x Screw for Impression coping 1x Cap for Impression coping closed tray
ZIRKONZAHN SRL
BSAQ4072
In Commercial Distribution

  • D800BSAQ4072 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Set consisting of: 1x Impression coping NON HEX 1x Screw for Impression coping 1x Cap for Impression coping closed tray
ZIRKONZAHN SRL
BSAQ4071
In Commercial Distribution

  • D800BSAQ4071 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Set consisting of: 1x Impression coping NON HEX 1x Screw for Impression coping 1x Driver for Impression coping open tray
ZIRKONZAHN SRL
BSAQ4064
In Commercial Distribution

  • D800BSAQ4064 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Set consisting of: 1x Impression coping NON HEX 1x Screw for Impression coping 1x Driver for Impression coping open tray
ZIRKONZAHN SRL
BSAQ4063
In Commercial Distribution

  • D800BSAQ4063 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Set consisting of: 1x Impression coping NON HEX 1x Screw for Impression coping 1x Driver for Impression coping open tray
ZIRKONZAHN SRL
BSAQ4062
In Commercial Distribution

  • D800BSAQ4062 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Set consisting of: 1x Impression coping NON HEX 1x Screw for Impression coping 1x Driver for Impression coping open tray
ZIRKONZAHN SRL
BSAQ4061
In Commercial Distribution

  • D800BSAQ4061 ()


  • Dental implant suprastructure, temporary, preformed, reusable
VALIDATE THY2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: Thyroglobulin (Tg).
Lgc Clinical Diagnostics, Inc.
908ro
In Commercial Distribution

  • 00850011135600 ()


  • Thyroglobulin IVD, control
Standard Imaging Stereotactic Dose Verification Phantom can be used for a wide variety of tests including routine absolute dosimetry output checks and treatment planning system(TPS) commissioning and quality assurance(QA) tests as recommended by TG 53 and IEC 430 Treatment Planning System Commissioning and QA Standards. Patient specific dosimetry tests can be performed easily as well.
STANDARD IMAGING INC.
91250
In Commercial Distribution

  • 00850019946529 ()
91250

  • Multi-modality therapeutic radiation phantom, test object
The ZEISS® Connect App mobile application will be an optional accessory of ZEISS® UNO 3 microscope product. ZEISS® Connect application SW will be available to the end user as an iOS app and user should be able to download and install the same from Apple App store. ZEISS® Connect App will pair wirelessly to the UNO3 variants of microscope and associated peripheral devices (like monitor etc.). This database entry covers UDI for SW version 2.0 and higher. Version 2.0-> UDI - (01)04049539070135(10)200-> Version 3.0-> UDI - (01)04049539070135(10)301 ->Version 4.2-> UDI - (01)04049539070135(10)420
Carl Zeiss Meditec AG
2.0
In Commercial Distribution

  • 04049539070135 ()


  • Multidisciplinary medical image management software
MyNotifiRX: Is a Bluetooth wearable device that interacts with a patient’s smart phone via an app (iOS or android). All data is sent by wifi to a HIPAA controlled server for real time or accumulated time review by the provider. MyNotifiRX can be used to meet the rehabilitation needs of any extremity after injury. It can be used both pre and post-operatively to meet a patient’s rehabilitation needs. It is designed for acute or chronic use especially in patients at high risk for falls. As an added feature it is designed with a fall detection algorithm to alert designated care givers in the case of an emergency independent of a patient’s ability to respond. It is designed with two functions. 1) In patients who are evaluated to be at risk for falls, MyNotifi can act as a Fall protection device and monitor. It has a built in algorithm to detect when a possible fall occurs and alerts those that the wearer has designated that an issue has occurred. It is also imbedded with the OTAGO exercise protocol https://www.apta.org/PTinMotion/NewsNow/?blogid=10737418615&id=10737430053 ) which is clinically proven to help prevent falls by improving balance. Long term remote monitoring of patients to assist, adjust, advance or correct exercise regimen is possible. Even more important, it can serve as a means to catch early deterioration of function and signal the need for intervention before an accident occurs. 2) With its magnetic strip and extension band, it can be placed on any extremity to record an exercise regimen programmed by the provider. There is a library of over 40 APTA exercises (attach sheet) that can be selected. It is recommended for use in upper extremity patients for both nonoperative and post-operative rehabilitation. MyNotifi is best suited in the lower extremity for the rehab of non surgical patients. The addition of a monitor to measure heart rate and blood oxygenation during exercise adds to patient safety and serves as a measure of physical exertion during
MEDHAB, LLC
Version 2
In Commercial Distribution

  • 00850023296023 ()
MyNotifi RX - small

  • Bed/chair occupant movement pressure/vibration sensor
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