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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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SB Mat Evolution - B970SBMAT0

Includes (2) 3140 Sensors installed in floor display with 2 Evolution Handles, FootMat for Research Software CD with 3140D-1 Map, Help File, and 1 Web-Based Training Session
Tekscan, Inc.
Sports Balance Mat
In Commercial Distribution

  • B970SBMAT0 ()
SBMAT

  • Body-surface pressure mapping system

ADAMII - 08809317540627

ADAMII is a device to count stained CD series (e.g. CD34, CD3, CD4, CD8, CD45, etc.) in human sample as an aid in the management of patients.
NanoEnTek, Inc.
ADAMII
In Commercial Distribution

  • 08809317540627 ()


  • Haematological cell analyser IVD

Welch Allyn, Inc. - 00732094262919

Surveyor Central Additional Control - configured CPU Italian language and CD manual; 220V power; 4 monitoring slots (single display required with additional CPU); No printer; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262919 ()
SCAC-AEB-AXXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262902

Surveyor Central Additional Control - configured CPU Italian language and CD manual; 220V power; 8 monitoring slots (single display required with additional CPU); No printer; No display monitor
WELCH ALLYN, INC.
901137
Not in Commercial Distribution

  • 00732094262902 ()
SCAC-AEB-BXXXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094262445

Surveyor Central Review Station - English language and CD manual; 220V power; Turnkey system includes configured CPU with DVD+/-RW drive; No printer; No display monitor; No interpretation
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262445 ()
SCREV-AAB-AXXXX

  • Centralized patient monitor

ACTEON - 03609820553672

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

ACTEON - 03609820027203

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

MCB Series - 00817492021044

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

Liofilchem MTS (MIC Test Strip) - 18055182870124

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

CONFORMat Evolution - B970CE10

Includes 1 Evolution Handle, CONFORMat Clinical Software CD with CONFORMat Map, (1) 5330 Sensor, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
CONFORMat 1 System
In Commercial Distribution

  • B970CE10 ()
CE1

  • Body-surface pressure mapping system
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