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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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 Syringe. Italian..
SCIENTIFIC PHARMACEUTICALS, INC.
ID 65-024 I
In Commercial Distribution

  • D801ID65024I1 ()
65-024

  • Dentine adhesive
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
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