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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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Implant Analog (B) - 00841549117244

Stainless Steel. Implant analogs are replicas of many popular implant platforms used during the fabrication of a master cast. The implant analog is placed in the laboratory stone or plaster model in the location and position determined for the final prosthesis.
STERNGOLD DENTAL LLC
904533
In Commercial Distribution

  • 00841549117244 ()


  • Dental implant analog

Standard B Solution - 00811403015887

To provide calibration points for the Na, K, and Cl electrodes on the Medica ISE Module Analyzer.
Diamond Diagnostics Inc.
ME-5410D
In Commercial Distribution

  • 00811403015887 ()


  • Multiple electrolyte IVD, calibrator

Vitrification Kit (B) - 24582231462647

Contains VT601US(ES,VS×2), 4 of cryotopUSs(Blue)and Repro Plate
KITAZATO CORPORATION
VT601US-TOP(B)
In Commercial Distribution

  • 24582231462647 ()
  • 14582231462596 ()


  • IVF medium kit

Anti-A,B (AB03) - 23661562105223

Blood Grouping Reagent, Anti-A,B (Murine Monoclonal) (152D12+9113D10) - This reagent is designed to determine the presence of ABO system blood group antigen A and B on the surface of human red blood cells by manual tube method.
DIAGAST
210522
In Commercial Distribution

  • 23661562105223 ()
  • 13661562105226 ()
210522

  • Anti-AB red blood cell grouping IVD, antibody

Tip Calibrator B - 07540209955259

Tip calibrator B for Navient
ClaroNav Kolahi Inc
950-NE-TC-B
In Commercial Distribution

  • 07540209955259 ()


  • Neurological stereotactic surgery system

Registration probe B - 07540209955211

Registration probe B for Navient
ClaroNav Kolahi Inc
950-NE-RP-B
In Commercial Distribution

  • 07540209955211 ()


  • Neurological stereotactic surgery system

Maxillary Seeker B - 07540209955198

Maxillary Seeker B for Navient
ClaroNav Kolahi Inc
950-NE-MS-B
In Commercial Distribution

  • 07540209955198 ()


  • Neurological stereotactic surgery system

Frontal Seeker B - 07540209955181

Frontal seeker B for Navient
ClaroNav Kolahi Inc
950-NE-FS-B
In Commercial Distribution

  • 07540209955181 ()


  • Neurological stereotactic surgery system

CHANG Medium B - 00810195240606

CHANG Medium Basal. 90mL bottle.
IRVINE SCIENTIFIC, LLC
C100-90ML
In Commercial Distribution

  • 00810195240606 ()
C100

  • Cell culture medium IVD

Standard B Solution - 00811403010172

To provide calibration points for the Na, K & Cl electrodes for AVL 982, 983 Analyzers.
Diamond Diagnostics Inc.
AV-BP0442D
In Commercial Distribution

  • 00811403010172 ()


  • Multiple electrolyte IVD, calibrator
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