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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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RAN-11125NBB, F/G PN 74269-01M
RANFAC CORP.
11 Gauge x 125mm
In Commercial Distribution

  • 20858690006062 ()
  • 10858690006065 ()
  • 00858690006068 ()
  • 30858690006069 ()
  • 40858690006066 ()

  • Length: 125 Millimeter
  • Needle Gauge: 11 Gauge
RAN-11125NBB

  • Bone access cannula
RBN-84, F/G P/N 74224-01M
RANFAC CORP.
8 Gauge x 4"
In Commercial Distribution

  • 20858690006055 ()
  • 10858690006058 ()
  • 00858690006051 ()

  • Length: 4 Inch
  • Needle Gauge: 8 Gauge
RBN-84

  • Bone marrow biopsy needle, single-use
Software Disk
Fujirebio Diagnostics, Inc.
CL0004
In Commercial Distribution

  • 00869164000017 ()


  • Laboratory instrument/analyser application software IVD
Pak12G assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens and to epitopes on the platelet glycoproteins IIb/IIIa, Ia/IIa, and Ib/IX.
IMMUCOR GTI DIAGNOSTICS, INC.
PAK12G
Not in Commercial Distribution

  • 10888234500223 ()
PAK12G

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)
No Description
REMEL EUROPE LIMITED
R30951201
In Commercial Distribution

  • 05056080501451 ()


  • Beta-haemolytic Streptococcus serological grouping IVD, reagent
No Description
KITAZATO CORPORATION
Cryotop US(G)
In Commercial Distribution

  • 14582231462893 ()
  • 04582231462896 ()
81171

  • Assisted reproduction vitrification carrier
3M™ ESPE™ Cavit™-G Temporary Filling Material Refill, 44313
3M Deutschland GmbH
44313
In Commercial Distribution

  • J001702011046610 ()
44313

  • Fatty acid dental cement
No Description
DETAX GmbH
04014
In Commercial Distribution

  • EDET040141 ()


  • Denture reliner, elastic, long-term
Alginate for dental impressions
VANNINI DENTAL INDUSTRY SRL
002015
In Commercial Distribution

  • 38033712560268 ()
  • 08033712560267 ()

  • Total Volume: 27280 Milliliter
002015

  • Alginate dental impression material
Alginate for dental impressions
VANNINI DENTAL INDUSTRY SRL
002025
In Commercial Distribution

  • 38033712560251 ()
  • 08033712560250 ()

  • Total Volume: 27280 Milliliter
002025

  • Alginate dental impression material
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