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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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Foam Mattress Pads - 00810044960761

FULL Convolute Mattress Topper 3" X 54" X 75" Density # 1.2
GENEVA HEALTHCARE, LLC
CM-35475D
In Commercial Distribution

  • 00810044960761 ()
CM-35475D

  • Leishmania donovani immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Drill Stopper for Long L11.5 1856 - 07290105157638

No Description
ADIN DENTAL IMPLANT SYSTEMS LTD
S1856L11.5
In Commercial Distribution

  • 07290105157638 ()


  • Borna disease virus immunoglobulin G (IgG) antibody IVD, reagent

Access SARS-CoV-2 IgG II QC - 15099590742768

The Access SARS-CoV-2 IgG II QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG II assay using the Access Immunoassay Systems only. The Access SARS-CoV-2 IgG II QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69059
In Commercial Distribution

  • 15099590742768 ()
C69059

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Access SARS-CoV-2 IgG QC - 15099590738662

The Access SARS-CoV-2 IgG QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG assay. The Access SARS-CoV-2 IgG QC is for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgG QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58964
In Commercial Distribution

  • 15099590738662 ()
C58964

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

NA - 00885556045695

O.F. 32MM X 50/54 OD ACET LNR W/20 DEG
Smith & Nephew, Inc.
71927746
In Commercial Distribution

  • 00885556045695 ()
71927746

  • Ceramic acetabular liner

NA - 00885556024669

ACETABULAR LINER 32MM Inner Diameter 63-70MM Outer Diameter 20 DEGREE
Smith & Nephew, Inc.
71343263
In Commercial Distribution

  • 00885556024669 ()
71343263

  • Ceramic acetabular liner

NA - 00885556024003

ACETABULAR LINER 22MM ID 63-70MM OD 0 DEGREE
Smith & Nephew, Inc.
71342063
In Commercial Distribution

  • 00885556024003 ()
71342063

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556022894

R3 36MM ID US CERAMIC ACET LINER MM58
Smith & Nephew, Inc.
71338958
In Commercial Distribution

  • 00885556022894 ()
71338958

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556022313

R3 36MM ID US CERAMIC ACET LINER MM66/68
Smith & Nephew, Inc.
71338966
In Commercial Distribution

  • 00885556022313 ()
71338966

  • Ceramic acetabular liner

NA - 00885556022122

ACETABULAR LINER 32MM Inner Diameter 63-70MM Outer Diameter 0 DEGREE
Smith & Nephew, Inc.
71340263
In Commercial Distribution

  • 00885556022122 ()
71340263

  • Ceramic acetabular liner
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