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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reSET® Mobile Application running on iOS. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Introductory Access Limited Version provides limited access to the reSET product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008149 ()


  • Mental health/function therapeutic software, screen-viewed
No Description
Starkey Laboratories, Inc.
Thrive Hearing Control for iOS
In Commercial Distribution

  • 00842318130792 ()


  • Audiometric/hearing device software
The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
GLOOKO, INC.
5.xx
In Commercial Distribution

  • 00855093008033 ()


  • Clinical management support software
Sterlization Container, 1/1 bottom perforated 585x274x116 mm
SBH Surgical
SB 106.135E - Non Perforated Bot.
In Commercial Distribution

  • 00850068304219 ()
SB 106.135E

  • Device sterilization/disinfection container, reusable
The Bal. Pro Pants-Bot. conn w/o print inflatable garment is fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion.
MEGO afek Agricultural Cooperative Society Ltd
Bal Pants Bot conn NP
In Commercial Distribution

  • 07290105875051 ()
L4MP4122

  • Multi-chamber venous compression system garment, reusable
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNXS
In Commercial Distribution

  • B660RMNXS0 ()


  • Voice synthesizer/digitizer
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNXL
In Commercial Distribution

  • B660RMNXL0 ()


  • Voice synthesizer/digitizer
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNS
In Commercial Distribution

  • B660RMNS0 ()


  • Voice synthesizer/digitizer
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMN
In Commercial Distribution

  • B660RMN0 ()


  • Voice synthesizer/digitizer
No Description
NT-Trading GmbH & Co. KG
UTG 80500000
Not in Commercial Distribution

  • ENTTUTG805000001 ()

  • Diameter: Ø 5,0 mm Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 80500000

  • Dental implant suprastructure, permanent, preformed
  • Dental prosthesis/implant abutment screw
No Description
NT-Trading GmbH & Co. KG
UTG 605000
Not in Commercial Distribution

  • ENTTUTG6050001 ()

  • Diameter: Ø 5,0 mm Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 605000

  • Dental implant suprastructure, permanent, preformed
  • Dental prosthesis/implant abutment screw
Thyroglobulin Sample Diluent - IMMULITE -- 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387046
In Commercial Distribution

  • 00630414954301 ()
LTYZ

  • Buffered sample diluent IVD
Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
GLOOKO, INC.
5.x
In Commercial Distribution

  • 00855093008002 ()


  • Clinical management support software
No Description
NT-Trading GmbH & Co. KG
UTG 80334200
Not in Commercial Distribution

  • ENTTUTG803342001 ()

  • Diameter: Ø 3,3 - 4,25 mm Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 80334200

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG 603342
Not in Commercial Distribution

  • ENTTUTG6033421 ()

  • Diameter: Ø 3,3 - 4,25 mm Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 603342

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
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
BSAQ4074
In Commercial Distribution

  • D800BSAQ4074 ()


  • 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
BSAQ4073
In Commercial Distribution

  • D800BSAQ4073 ()


  • 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
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
Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: anti-thyroperoxidase TPO , anti-thyroglobulin TG , anti- TSH receptor R-TSH .
THERADIAG SA
THYRO
In Commercial Distribution

  • 03760170782072 ()
HM 065US-2X05

  • Multiple thyroid antibody IVD, control
The Access Thyroglobulin Sample Diluent is intended for use with the Access Thyroglobulin Assay to dilute patient samples containing thyroglobulin (Tg) concentrations greater than the S5 calibrator.
Beckman Coulter, Inc.
33866
In Commercial Distribution

  • 15099590225858 ()
33866

  • Thyroglobulin IVD, kit, chemiluminescent immunoassay
TraumaGuard Intra-abdominal Pressure-Sensing Catheter (“TG”). TG is a urine drainage catheter that provides continuous biometric monitoring of Intra-abdominal Pressure (“IAP”) and Core Body Temperature (CBT). TG is a silicone catheter with polyurethane sensing balloons. IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The TraumaGuard Intra-abdominal Pressure-Sensing System Catheter is a single-use device intended for short-term use (less than 30 days).
SENTINEL MEDICAL TECHNOLOGIES
TraumaGuard Intra-abdominal Pressure-Sensing System Single Catheter
In Commercial Distribution

  • 00860003478707 ()
000-0219

  • Multi-parameter urinary monitoring system catheter set
RESET-O is an iOS application intended to increase retention of opioid use disorder patients in outpatient treatment by providing cognitive behavioral therapy as an adjunct to outpatient treatment.
Harvest Bio LLC
2.0.2
In Commercial Distribution

  • 00850074433019 ()


  • Mental health/function therapeutic software, screen-viewed
RESET Mobile Application runs on iOS and is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older.
Harvest Bio LLC
2.0.2
In Commercial Distribution

  • 00850074433002 ()


  • Mental health/function therapeutic software, screen-viewed
Anasept Antimicrobial Skin and Wound cleanser filled in 8 oz. cone top, HDPE bottles with Trigger sprayer
ARGENTUM MEDICAL, LLC
4008TC
In Commercial Distribution

  • 10856040008424 ()
  • 00856040008427 ()


  • Antimicrobial wound irrigation solution
No Description
NT-Trading GmbH & Co. KG
UTG 10.MI5.000.05
Not in Commercial Distribution

  • ENTTUTG10MI5000051 ()

  • Diameter: Ø 5,0 mm gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 10.MI5.000.05

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
ANTI-TG IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROGLOBULIN (TG) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.
ORGENTEC Diagnostika GmbH
ORG502
Not in Commercial Distribution

  • 04260157080010 ()
ORG502

  • Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
No Description
NT-Trading GmbH & Co. KG
UTG 10.MI3.342.05
Not in Commercial Distribution

  • ENTTUTG10MI3342051 ()

  • Diameter: Ø 3,3 - 4,25 mm gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 10.MI3.342.05

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8050002M
Not in Commercial Distribution

  • ENTTUTG2CON8050002M1 ()

  • 2-CONnect®-Abutment Ø 5,0 mm; gingiva height 2,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8050002M

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8050001M
Not in Commercial Distribution

  • ENTTUTG2CON8050001M1 ()

  • 2-CONnect®-Abutment Ø 5,0 mm; gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8050001M

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
SC TABLET MINI, SGD, WITH TDSNAP FOR iOS and iPad Mini. Small portable speech device for people who can not speak due to disability, injury or illness. High output speakers, durability and ingress protection for
TOBII DYNAVOX LLC
SC Tablet Mini
In Commercial Distribution

  • 07340074601929 ()
113527

  • Voice synthesizer/digitizer
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8050002S
Not in Commercial Distribution

  • ENTTUTG2CON8050002S1 ()

  • 2-CONnect®-Abutment Set Ø 5,0 mm; gingiva height 2,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8050002S

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8050001S
Not in Commercial Distribution

  • ENTTUTG2CON8050001S1 ()

  • 2-CONnect®-Abutment Set Ø 5,0 mm; gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8050001S

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8033422M
Not in Commercial Distribution

  • ENTTUTG2CON8033422M1 ()

  • 2-CONnect®-Abutment Ø 3,3 - 4,25 mm; gingiva height 2,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8033422M

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8033421M
Not in Commercial Distribution

  • ENTTUTG2CON8033421M1 ()

  • 2-CONnect®-Abutment Ø 3,3 - 4,25 mm; gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8033421M

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
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
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 80500A3M
Not in Commercial Distribution

  • ENTTUTG2CON80500A3M1 ()

  • 2-CONnect®-Abutment Ø 5,0 mm; gingiva height 2,5 mm; angled 20°; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 80500A3M

  • Dental implant suprastructure, permanent, preformed
  • Dental prosthesis/implant abutment screw
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8033422S
Not in Commercial Distribution

  • ENTTUTG2CON8033422S1 ()

  • 2-CONnect®-Abutment Set Ø 3,3 - 4,25 mm; gingiva height 2,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8033422S

  • Dental implant suprastructure, permanent, preformed
  • Dental prosthesis/implant abutment screw
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8033421S
Not in Commercial Distribution

  • ENTTUTG2CON8033421S1 ()

  • 2-CONnect®-Abutment Set Ø 3,3 - 4,25 mm; gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8033421S

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 80500A3S
Not in Commercial Distribution

  • ENTTUTG2CON80500A3S1 ()

  • 2-CONnect®-Abutment Set Ø 5,0 mm; gingiva height 2,5 mm; angled 20°; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 80500A3S

  • Dental implant suprastructure, permanent, preformed
  • Dental prosthesis/implant abutment screw
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
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
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an IOS platform.
SPAULDING MEDICAL
1.3.6.1
In Commercial Distribution

  • B441SMIOSCLIENTAPP0 ()
SMIOSCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
iOS application portion for Salux™ Tablet-Controlled Audiometer system. The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI Standard 3.6. The Salux™ Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux™ Audiometer solution can be used to display video or static content to the participant.
Examinetics, Inc.
SALUX-SW-02
In Commercial Distribution

SALUX-SW-02

  • Tone audiometer, semi-automated
iOS application portion for Salux™ Tablet-Controlled Audiometer system. The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI Standard 3.6. The Salux™ Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux™ Audiometer solution can be used to display video or static content to the participant.
Examinetics, Inc.
SALUX-SW-01
In Commercial Distribution

  • 00860007826627 ()
SALUX-SW-01

  • Tone audiometer, semi-automated
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
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