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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Personalized PseudoPatient™ PV IC
RTSAFE, INC.
PIC-02PV
In Commercial Distribution

  • 00860001523201 ()
PIC-02PV

  • Custom-made organ/bone anatomy model
The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.
CORTICAL METRICS, LLC
1.0
In Commercial Distribution

  • 00860000709408 ()

  • Depth: 73 Millimeter
  • Width: 113 Millimeter
  • Height: 40 Millimeter


  • Cognitive assessment software
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 22.5°C.
Temptime Corporation
CT12
In Commercial Distribution

  • 00852282007129 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 9 months at 22.5°C.
Temptime Corporation
CT9
In Commercial Distribution

  • 00852282007105 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 22.5°C.
Temptime Corporation
CT3
In Commercial Distribution

  • 00852282007075 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 9 months at 5°C.
Temptime Corporation
F9
In Commercial Distribution

  • 00852282007020 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 36 months at 22.5°C.
Temptime Corporation
CT36
In Commercial Distribution

  • 00852282007136 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 24 months at 22.5°C.
Temptime Corporation
CT24
In Commercial Distribution

  • 00852282007112 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 182 days at 22.5°C.
Temptime Corporation
CT6
In Commercial Distribution

  • 00852282007099 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 121 days at 22.5°C.
Temptime Corporation
CT4
In Commercial Distribution

  • 00852282007082 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 60 days at 22.5°C.
Temptime Corporation
CT2
In Commercial Distribution

  • 00852282007068 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 36 months at 5°C.
Temptime Corporation
F36
In Commercial Distribution

  • 00852282007051 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 24 months at 5°C.
Temptime Corporation
F24
In Commercial Distribution

  • 00852282007044 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 5°C.
Temptime Corporation
F12
In Commercial Distribution

  • 00852282007037 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 182 days at 5°C.
Temptime Corporation
F6
In Commercial Distribution

  • 00852282007013 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 5°C.
Temptime Corporation
F3
In Commercial Distribution

  • 00852282007006 ()


  • Medical product temperature point indicator, thermochemical
Resin root canal sealer for dental endodontic treatment
MICRO MEGA
none
In Commercial Distribution

  • J015206000360 ()
20600106

  • Endodontic filling/sealing material
HemaPrompt fecal occult blood test
AERSCHER, INC
HP
In Commercial Distribution

  • 00693501000220 ()
  • 00069350100022 ()


  • Faecal occult blood IVD, reagent
HemaPrompt FG Fecal and Gastric Test Kit
AERSCHER, INC
HPFG
In Commercial Distribution

  • 00693501000152 ()
  • 00069350100015 ()


  • Biological fluid occult blood screening IVD, kit, rapid colorimetric, clinical
AH Plus Jet Refill Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe delivery for homogeneous mixing of both pastes.
Dentsply De Trey GmbH
667007
In Commercial Distribution

  • D0106670071 ()
  • D0106670070 ()

  • Paste
  • Weight: 15 Gram
667007

  • Endodontic filling/sealing material
AH Plus Jet Starter Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe delivery for homogeneous mixing of both pastes. With its supporting accessories (Mixing/Intraoral Tips, Mixing Pad and Organizer Tray) it can be classified as a convenience kit.
Dentsply De Trey GmbH
667005
In Commercial Distribution

  • D0106670051 ()

  • Weight: 15 Gram
  • Paste
667005

  • Endodontic filling/sealing material
AH Plus Kit is a two-component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Root Canal Sealer in tubes for manual mixing of Paste A + B. With its supporting accessory (Mixing Pad) it can be classified as a convenience kit.
Dentsply De Trey GmbH
667003
In Commercial Distribution

  • D0106670031 ()

  • Paste
  • Total Volume: 4 Milliliter
667003

  • Endodontic filling/sealing material
SmartLite Focus Power Connector is a part of the SmartLite Focus Curing Light and is available separately.
Dentsply De Trey GmbH
64450050
In Commercial Distribution

  • D010644500501 ()

  • Length: 7.5 Centimeter
64450050

  • Dental/surgical polymerization lamp
SmartLite Focus Eye Protection Sields are a part of the SmartLite Focus Curing Light and are available separately.
Dentsply De Trey GmbH
64450040
In Commercial Distribution

  • D010644500400 ()
  • D010644500401 ()

  • Outer Diameter: 2 Centimeter
64450040

  • Dental/surgical polymerization lamp
SmartLite Focus Battery Pack is a part of the SmartLite Focus Curing Light and is available separately.
Dentsply De Trey GmbH
64450021
In Commercial Distribution

  • D010644500211 ()

  • Length: 5.9 Centimeter
64450021

  • Dental/surgical polymerization lamp
Automatrix Snippers+ is a scissors-like tool for removal of Automatrix system bands by clipping off the Auto-Lock loop.
Dentsply De Trey GmbH
62422601
In Commercial Distribution

  • D010ASN0 ()
  • D010624226011 ()

  • Length: 17 Centimeter
62422601

  • Orthodontic pliers
VISCO GEL Standard Pack is a self-curing, resilient methacrylate formulation, intended for use as a limited-term soft linig material for complet and partial dentures. Visco-gel is received in 2 components powder (D010K2006000) and liquid (D010K3006010) both of them in a bottle delivery. With an additional bottle of a separator (D010K3006020) and its supporting accessories (Mixing Bowl, Powder Measure and Liquid Measure) it can be classified as a convenience kit.
Dentsply De Trey GmbH
61605002
In Commercial Distribution

  • D010616050021 ()

  • Weight: 120 Gram
  • Liquid
  • Total Volume: 15 Milliliter
  • Total Volume: 90 Milliliter
  • Powder
61605002

  • Denture reliner, soft, professional
Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667354
In Commercial Distribution

  • D010606673541 ()
60667354

  • Dentine bonding agent/set
Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667353
In Commercial Distribution

  • D010606673531 ()
60667353

  • Dentine bonding agent/set
Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667348
In Commercial Distribution

  • D010606673481 ()
60667348

  • Dentine bonding agent/set
Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667347
In Commercial Distribution

  • D010606673471 ()
60667347

  • Dentine bonding agent/set
Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667345
In Commercial Distribution

  • D010606673451 ()
60667345

  • Dentine bonding agent/set
Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667344
In Commercial Distribution

  • D010606673441 ()
60667344

  • Dentine bonding agent/set
Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667343
In Commercial Distribution

  • D010606673431 ()
60667343

  • Dentine bonding agent/set
Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667342
In Commercial Distribution

  • D010606673421 ()
60667342

  • Dentine bonding agent/set
Prime&Bond active Standard Refill universal adhesive is a combined Etch&Rinse (Total Etch), Self Etch and Selective Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667341
In Commercial Distribution

  • D010606673411 ()

  • liquid
  • Total Volume: 4 Milliliter
60667341

  • Dentine bonding agent/set
Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.
Dentsply De Trey GmbH
60667340
In Commercial Distribution

  • D010606673401 ()
60667340

  • Dentine bonding agent/set
AH Plus Jet endodontic sealer in syringes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin. The double-barrel syringes with disposable mixing tips for intraoral use offer a more precise, convenient and faster procedure. AH Plus endodontic sealer functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus endodontic sealer does not stain teeth.
Dentsply De Trey GmbH
60620118NA
In Commercial Distribution

  • D01060620118NA0 ()
  • D01060620118NA1 ()

  • Weight: 30 Gram
60620118NA

  • Dental epoxy resin
AH Plus Jet Refill Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe (D010606201180) delivery for homogeneous mixing of both pastes.
Dentsply De Trey GmbH
60620118
In Commercial Distribution

  • D010606201181 ()
  • D010606201180 ()

  • Weight: 15 Gram
  • Paste
60620118

  • Endodontic filling/sealing material
AH Plus Jet endodontic sealer in syringes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin. The double-barrel syringes with disposable mixing tips for intraoral use offer a more precise, convenient and faster procedure. AH Plus endodontic sealer functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus endodontic sealer does not stain teeth.
Dentsply De Trey GmbH
60620115NA
In Commercial Distribution

  • D01060620115NA1 ()

  • Weight: 15 Gram
60620115NA

  • Dental epoxy resin
AH Plus Jet Starter Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe (D010K3001600) delivery for homogeneous mixing of both pastes. With its supporting accessories (Mixing/Intraoral Tips, Mixing Pad and Organizer Tray) it can be classified as a convenience kit.
Dentsply De Trey GmbH
60620115
In Commercial Distribution

  • D010606201151 ()

  • Weight: 15 Gram
  • Paste
60620115

  • Endodontic filling/sealing material
AH Plus endodontic sealer in tubes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin for an easy manual mix. It functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus endodontic sealer does not stain teeth.
Dentsply De Trey GmbH
60620110NA
In Commercial Distribution

  • D01060620110NA1 ()

  • Total Volume: 8 Milliliter
60620110NA

  • Dental epoxy resin
AH Plus Refill Kit is a two-component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Root Canal Sealer in tubes for manual mixing of Paste A + B (D010K3018020 and D010K3018030). With its supporting accessory (Mixing Pad) it can be classified as a convenience kit.
Dentsply De Trey GmbH
60620110
In Commercial Distribution

  • D010606201101 ()

  • Paste
  • Total Volume: 4 Milliliter
60620110

  • Endodontic filling/sealing material
AH 26 Refill is a 2 component powder/resin root canal filling material consisting of a powder jar (D010K3019010) and a resin tube (D010K3019120)
Dentsply De Trey GmbH
60620101
In Commercial Distribution

  • D010606201011 ()
  • D010606201010 ()

  • Weight: 8 Gram
  • Paste
  • Powder
  • Weight: 10 Gram
60620101

  • Endodontic filling/sealing material
AH 26 SILVERFREE RESIN Refill is a refill item of the 2 component powder/resin root canal filling material containing a resin tube (D010K3019120).
Dentsply De Trey GmbH
60620002
In Commercial Distribution

  • D010606200021 ()

  • Paste
  • Weight: 10 Gram
60620002

  • Endodontic filling/sealing material
Capsule Extruder 2 is the device designed for extrusion and direct application of ChemFil® Rock restorative capsules
Dentsply De Trey GmbH
60606596
In Commercial Distribution

  • D010606065960 ()
  • D010606065961 ()

  • Length: 17.5 Centimeter
60606596

  • Dental material cartridge-plunging applicator, single-component
SDR® Plus Collectors Edition
DENTSPLY INTERNATIONAL INC.
60603048
In Commercial Distribution

  • D010606030481 ()
60603048

  • Dental composite resin
SDR® Plus Compula Intro Kit
DENTSPLY INTERNATIONAL INC.
60603047
In Commercial Distribution

  • D010606030471 ()
60603047

  • Dental composite resin
SDR® Plus Syringe ECO Refill
DENTSPLY INTERNATIONAL INC.
60603045
In Commercial Distribution

  • D010606030450 ()
  • D010606030451 ()
60603045

  • Dental composite resin
Aquasil Ultra Heavy RS Cartridge Bulk Refill
DENTSPLY INTERNATIONAL INC.
678275
In Commercial Distribution

  • D0026782750 ()
  • D0026782751 ()
678275

  • Silicone dental impression material
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