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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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SYSTEM 5 Multicuff Kit,Multicuff, 1 pc Cuffs
AMERICAN DIAGNOSTIC CORP
740-MCC1
In Commercial Distribution

  • 00634782597825 ()
  • 00634782096441 ()

  • 5 Cuff, 13-66cm
740-MCC1

  • Aneroid manual sphygmomanometer
Alternate name : Cytokeratin 5/6 (CK 5/6)
BIOCARE MEDICAL LLC
PM105AA
In Commercial Distribution

  • 00847627010995 ()


  • Cytokeratin IVD, antibody
No Description
BIOCARE MEDICAL LLC
PME430AA
In Commercial Distribution

  • 00847627012043 ()


  • Cytokeratin IVD, antibody
1- OF6030 1- BF6020 1-BF516
SUNSET HEALTHCARE SOLUTIONS, INC.
OF6030SP
In Commercial Distribution

  • 00848530104122 ()


  • Anaesthesia conduction filter
  • Respirator filter/cartridge, particulates
No Description
Cochlear Bone Anchored Solutions AB
95775
In Commercial Distribution

  • 09321502028677 ()

  • 5 M strength magnet
95775

  • Bone-conduction hearing implant system sound processor/vibrator
The device PointerShell 5mm is an instrument tracker adapter for image guided surgery for instruments shafts of 4.7mm to 5mm. The device is accessory to the Cube 4D Navigation system.
Fiagon GmbH
E012901
In Commercial Distribution

E012901

  • Multi-purpose stereotactic surgery system
MIRAFILL (BOX/5)-
HAGER WORLDWIDE, INC.
355439
In Commercial Distribution

  • D2483554391 ()


  • Manual dental scaler, reusable
No Description
IT-V Medizintechnik GmbH
P10107-512
In Commercial Distribution

  • 09120074395121 ()


  • Radiological whole-body positioner
No Description
OSADA ELECTRIC CO.,LTD.
SC point 5
In Commercial Distribution

  • 04582227360229 ()
16405

  • Ultrasonic dental scaling/debridement system handpiece tip, endodontic
No Description
TOKYO BOEKI MEDISYS INC.
50-27-0782
In Commercial Distribution

  • 04580262046528 ()
50-27-0782

  • Wash/cleaning solution IVD, automated/semi-automated system
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