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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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No Description
MAR COR PURIFICATION, INC.
MCB 202-100 CD BICARB SNGL SYS
In Commercial Distribution

  • 00817492021044 ()

  • Weight: 125 Pound
  • Height: 61 Inch
  • Depth: 36 Inch
  • Width: 42 Inch


  • Haemodialysis bicarbonate solution preparation mixer
The SP Newtron module is a multi-clinic piezo-ultrasonic unit that drives four modes (Perio, Endo, Scaling and "Boost")
SATELEC
SP NEWT. USA CD F00184/1-2-10P
In Commercial Distribution

  • 03609820553672 ()
F55367

  • Ultrasonic dental scaling/debridement system
The PAM MINILED is a curing light using second generation L.E.D technology. It's one of the only lights able to polymerize almost all types of composite material available today.
SATELEC
MINILED OEM CD P107 OPT OPA7.5
In Commercial Distribution

  • 03609820027203 ()
F02720

  • Dental/surgical polymerization lamp
No Description
LIOFILCHEM SRL
Clindamycin CD 0.016-256 100 MTS canister
In Commercial Distribution

  • 08055182870127 ()
  • 18055182870124 ()
920720

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - HL7 Integration Engine The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NHL7
In Commercial Distribution

  • 07290110252595 ()
HASP-SW-K-NHL7IE-01

  • Medical equipment clinical data interfacing software
Surveyor Central Review Station - English language and CD manual; 220V power; Software kit; No printer; No display monitor; VERITAS analysis algorithm with 12-lead ECG interpretation and UNIPRO export
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262438 ()
SCREV-AAB-BXXAX

  • Centralized patient monitor
Surveyor Central Review Station - German language and CD manual; 220V power; Software kit; No printer; No display monitor; VERITAS analysis algorithm with 12-lead ECG interpretation and UNIPRO export
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262414 ()
SCREV-ADB-BXXAX

  • Centralized patient monitor
Surveyor Central Review Station - Italian language and CD manual; 220V power; Software kit; No printer; No display monitor; VERITAS analysis algorithm with 12-lead ECG interpretation and UNIPRO export
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262407 ()
SCREV-AEB-BXXAX

  • Centralized patient monitor
Surveyor Central Repeater Kit (requires Mortara security router and Mortara service installation) - French language and CD manual; 110V power; 0; Color LCD 24 in. monitor with high resolution
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094302387 ()
SCREP-BCA-XXBXX

  • Centralized patient monitor
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU, no display; International power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer ; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263398 ()
QS-6EB-DXEXB

  • Cardiopulmonary stress exercise monitoring system computer
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