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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self-contained biological indicator, 10e5 population, 100-count box printed in Italian
MESA LABORATORIES, INC.
10e5
In Commercial Distribution

  • M985IDEZS51 ()
  • M985IDEZS50 ()
IDEZS/5

  • Biological sterilization indicator
Visible Light-Cured Restorative, Resin Based. Universal Bonding Agent. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-121 I
In Commercial Distribution

  • D801ID50121I1 ()
50-121

  • Dental composite resin
e-vive II NMES System with Post-Op Brace; 2XL/3XL, Left (ITALIAN)
Motive Health, Inc.
CY-1000-312I
In Commercial Distribution

  • 00850022650055 ()

  • Length: 16 Inch
CY-1000-312I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System with Post-Op Brace; L/XL, Left (ITALIAN)
Motive Health, Inc.
CY-1000-311I
In Commercial Distribution

  • 00850022650048 ()

  • Length: 16 Inch
CY-1000-311I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System with Post-Op Brace; S/M, Left (ITALIAN)
Motive Health, Inc.
CY-1000-310I
In Commercial Distribution

  • 00850022650031 ()

  • Length: 16 Inch
CY-1000-310I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System with Post-Op Brace; 2XL/3XL, Right (ITALIAN)
Motive Health, Inc.
CY-1000-309I
In Commercial Distribution

  • 00850022650024 ()

  • Length: 16 Inch
CY-1000-309I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System with Post-Op Brace; L/XL, Right (ITALIAN)
Motive Health, Inc.
CY-1000-308I
In Commercial Distribution

  • 00850022650017 ()

  • Length: 16 Inch
CY-1000-308I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System with Post-Op Brace; S/M, Right (ITALIAN)
Motive Health, Inc.
CY-1000-307I
In Commercial Distribution

  • 00850022650000 ()

  • Length: 16 Inch
CY-1000-307I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Enamel Primer Bottle. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-052 I
In Commercial Distribution

  • D801ID60052I1 ()
60-052

  • Dentine adhesive
IDS Dental Polishing Paste for Composite Restoratives, Amalgams, and Castings. Italian
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-05
In Commercial Distribution

  • D801ID5005I1 ()
50-05

  • Dentifrice
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
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
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 7010 I
In Commercial Distribution

  • D801ID7010I1 ()
70-10

  • Dental composite resin
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 55-26 I
In Commercial Distribution

  • D801ID5526I1 ()
55-26

  • Glass ionomer dental cement
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
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 - 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
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
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
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