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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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SciPharm Pit & Fissure Sealer Bonding Agent - D801SP520121

Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enamel. Clear. Part B.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 52-012
In Commercial Distribution

  • D801SP520121 ()
52-012

  • Dental pit/fissure sealant

X-CUBE - 08809260470804

'1:1, Contra Angle(Lever Type #2) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL-02C
Saeshin Precision Co., Ltd.
X-CUBE #3
In Commercial Distribution

  • 08809260470804 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470798

'1:1, Contra Angle(Lever Type #1) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL-01C
Saeshin Precision Co., Ltd.
X-CUBE #2
In Commercial Distribution

  • 08809260470798 ()


  • Dental power tool system, line-powered

LABType™ CWD Class I C Locus Typing Test - Sample - 00814695024391

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695024391 ()
RSSOW1CRS

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

LABType™ CWD Class II DRB1 Typing Test - Sample - 00814695024384

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695024384 ()
RSSOW2B1S

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

LABType™ CWD Class I C Locus Typing Test - Sample - 00814695024377

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695024377 ()
RSSOW1CS

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

LABType™ CWD Class I B Locus Typing Test - Sample - 00814695024360

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695024360 ()
RSSOW1BS

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

LABType™ CWD Class I A Locus Typing Test - Sample - 00814695024353

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695024353 ()
RSSOW1AS

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

LABType™ XR Class I C Locus Typing Test - Sample - 00814695024346

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695024346 ()
RSSOX1CRS

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

LABType™ XR Class II DRB1 Typing Test - Sample - 00814695024339

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695024339 ()
RSSOX2B1S

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
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