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
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
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
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