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 Class Implantable

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Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Italian with cables
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(ITA)
In Commercial Distribution

  • 00850063034203 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph
Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Italian with cables
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(ITA)
In Commercial Distribution

  • 00850015266669 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph
EZTest Gas self-contained biological indicator, 10e6 population, 100-count box printed in Italian
MESA LABORATORIES, INC.
10e6
In Commercial Distribution

  • M985IDEZG61 ()
  • M985IDEZG0 ()
IDEZG/6

  • Biological sterilization indicator
E-Scribe ECG Data Management Workstation - Enterprise system, floating; Italian system language; Software Only
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094323115 ()
ESWKST-DEX-BXXXX

  • Patient health record information system application software
SciPharm CuRay Match Metal Primer for Veneers or Cast Restorations (Primet). Boxed. Italian
SCIENTIFIC PHARMACEUTICALS, INC.
ID 70-10 BI
In Commercial Distribution

  • D801ID7010BI1 ()
70-10

  • Dental composite resin
Until - An Advanced Eugenol Free Solution for Temporary Crown and Bridge Cementation. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 55-25 I
In Commercial Distribution

  • D801ID5525I1 ()
55-25

  • Glass ionomer dental cement
SciPharm CuRay Match Metal Primer for Veneers or Cast Restorations (Primet). Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 7010 I
In Commercial Distribution

  • D801ID7010I1 ()
70-10

  • Dental composite resin
Until - An Advanced Eugenol Free Solution for Temporary Crown and Bridge Cementation. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 55-26 I
In Commercial Distribution

  • D801ID5526I1 ()
55-26

  • Glass ionomer dental cement
Mesa Labs Smart-Read EZTest Biological Test Pack with Instant Readout Integrator
MESA LABORATORIES, INC.
10e6 italian/25 controls
Not in Commercial Distribution

  • M985SRSP625ID1 ()
  • M985SRSP625ID0 ()
SRSP6/25-ID

  • Biological sterilization indicator
E-Scribe ECG Data Management Workstation - Department system, node- locked; Italian system language; Software Only
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094323153 ()
ESWKST-AEX-BXXXX

  • Patient health record information system application software
E-Scribe ECG Data Management Workstation - Enterprise system, node- locked; Italian system language; Software Only
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094323139 ()
ESWKST-CEX-BXXXX

  • Patient health record information system application software
Surveyor Central Repeater Standalone - Italian language and CD manual; 220V power; No display monitor
WELCH ALLYN, INC.
901137
Not in Commercial Distribution

  • 00732094308778 ()
SCREP-CEB-XXXXX

  • Centralized patient monitor
Surveyor Central Repeater Node - Italian language and CD manual; 220V power; No display monitor
WELCH ALLYN, INC.
901137
Not in Commercial Distribution

  • 00732094285420 ()
SCREP-AEB-XXXXX

  • Centralized patient monitor
Self-Cured Resin for Sealing Occusal Fissures and Bonding Composite Restoratives to Etched Enamel. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-12
In Commercial Distribution

  • D801ID5012I1 ()
50-12

  • Dental composite resin
E-Scribe ECG Data Management Workstation - Department system, node-locked; Italian system language; 220V power; Software Kit;
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094265101 ()
ESWKST-AEB-BXXXX

  • Patient health record information system application software
E-Scribe ECG Data Management Workstation - Enterprise system, node-locked; Italian system language; 220V power; Software Kit;
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094265071 ()
ESWKST-CEB-BXXXX

  • Patient health record information system application software
E-Scribe ECG Data Management Workstation - Enterprise system, floating; Italian system language; 220V power; Software Kit;
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094265019 ()
ESWKST-DEB-BXXXX

  • Patient health record information system application software
CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Activator Liquid Bottle. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 55-303 I
In Commercial Distribution

  • D801ID55303I1 ()
55-303

  • Dental composite resin
CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Contrast Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 55-301 I
In Commercial Distribution

  • D801ID55301I1 ()
55-301

  • Dental composite resin
Surveyor Repeater Node with no Hardware Italian language and CD manual; 220V power; No display monitor
WELCH ALLYN, INC.
901140
Not in Commercial Distribution

  • 00732094325362 ()
SCREP-DEB-XXXXX

  • Centralized patient monitor
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Primer. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 65-021 I
In Commercial Distribution

  • D801ID65021I1 ()
65-021

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Syringe. Italian..
SCIENTIFIC PHARMACEUTICALS, INC.
ID 65-024 I
In Commercial Distribution

  • D801ID65024I1 ()
65-024

  • Dentine adhesive
CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Activator Paste Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 55-304 I
In Commercial Distribution

  • D801ID55304I1 ()
55-304

  • Dental composite resin
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Trial Size. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 65-12
In Commercial Distribution

  • D801ID6512I1 ()
65-12

  • Dentine adhesive
CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Part A, Natural Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 55-302 I
In Commercial Distribution

  • D801ID55302I1 ()
55-302

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade Incisal Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-222 I
In Commercial Distribution

  • D801ID50222I1 ()
50-222

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A4 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-219 I
In Commercial Distribution

  • D801ID50219I1 ()
50-219

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C4 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-218 I
In Commercial Distribution

  • D801ID50218I1 ()
50-218

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade B2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-217 I
In Commercial Distribution

  • D801ID50217I1 ()
50-217

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-216 I
In Commercial Distribution

  • D801ID50216I1 ()
50-216

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C3/D3Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-215 I
In Commercial Distribution

  • D801ID50215I1 ()
50-215

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade B3 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-214 I
In Commercial Distribution

  • D801ID50214I1 ()
50-214

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A3.5 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-212 I
In Commercial Distribution

  • D801ID50212I1 ()
50-212

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-211
In Commercial Distribution

  • D801ID50211I1 ()
50-211

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A3 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-210
In Commercial Distribution

  • D801ID50210I1 ()
50-210

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade Universal Opaque Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-224 I
In Commercial Distribution

  • D801ID50224I1 ()
50-224

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A1/B1 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-213 I
In Commercial Distribution

  • D801ID50213I1 ()
50-213

  • Dental composite resin
Fluid Warmer, 230V UNIT, 750ml/min
BELMONT INSTRUMENT CORPORATION
903-00001A-I
Not in Commercial Distribution

  • 70896128002038 ()


  • Warming/high-flow infusion pump
No Description
BELMONT INSTRUMENT CORPORATION
903-00024-I
Not in Commercial Distribution

  • 50896128002379 ()


  • Warming/high-flow infusion pump
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. Syringe. Non-Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 66-02 I
In Commercial Distribution

  • D801ID6602I1 ()
66-02

  • Dentine adhesive
Surveyor Central Review Station - Italian language and CD manual; 220V power; Software kit; No printer; No display monitor; No interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262391 ()
SCREV-AEB-BXXXX

  • Centralized patient monitor
No Description
BELMONT INSTRUMENT CORPORATION
903-00039A-I
Not in Commercial Distribution

  • 50896128002775 ()


  • Warming/high-flow infusion pump
No Description
BELMONT INSTRUMENT CORPORATION
903-00037A-I
Not in Commercial Distribution

  • 50896128002751 ()


  • Warming/high-flow infusion pump
Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 60 gram Green Gel Etch Refill Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 70-125 BI
In Commercial Distribution

  • D801ID70125BI1 ()
70-125

  • Dental etching solution
Surveyor Central Repeater Kit (requires Mortara security router and Mortara service installation) - Italian language and CD manual; 220V power; 0; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262476 ()
SCREP-BEB-XXXXX

  • Centralized patient monitor
E-Scribe ECG Data Management Server - Department system; Italian system language; Software kit; No modem connections; No worklists; No advanced automatic workflow; No analysis options
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094323009 ()
ESCRIBE-AEX-CXXXX

  • Patient health record information system application software
E-Scribe ECG Data Management Server - Department system; Italian system language; Software kit; No modem connections; Customizable worklists; No advanced automatic workflow; VERITAS automatic serial comparison
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094323023 ()
ESCRIBE-AEX-CXAXA

  • Patient health record information system application software
E-Scribe ECG Data Management Server - Department system; Italian system language; Software kit; No modem connections; No worklists; No advanced automatic workflow; VERITAS automatic serial comparison
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094323016 ()
ESCRIBE-AEX-CXXXA

  • Patient health record information system application software
E-Scribe ECG Data Management Server - Enterprise system; Italian system language; Software kit; No modem connections; No worklists; No advanced automatic workflow; VERITAS automatic serial comparison
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094322903 ()
ESCRIBE-BEX-CXXXA

  • Patient health record information system application software
Surveyor Central Additional Control - configured CPU Italian language and CD manual; 220V power; Custom display and control (Project Management required); No printer; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094285475 ()
SCAC-AEB-EXXXX

  • Centralized patient monitor
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