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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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48/28MM BH DUAL MOBILITY INSERT
Smith & Nephew, Inc.
74121648
In Commercial Distribution

  • 00885556577233 ()
74121648

  • Ceramic acetabular liner
38/22MM BH DUAL MOBILITY INSERT
Smith & Nephew, Inc.
74121638
In Commercial Distribution

  • 00885556577189 ()
74121638

  • Ceramic acetabular liner
REFLECTION XLPE 36MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETER SIZE G ETO
Smith & Nephew, Inc.
71331316
In Commercial Distribution

  • 00885556535196 ()
71331316

  • Ceramic acetabular liner
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)
No Description
ADIN DENTAL IMPLANT SYSTEMS LTD
S1856L11.5
In Commercial Distribution

  • 07290105157638 ()


  • Borna disease virus immunoglobulin G (IgG) antibody IVD, reagent
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
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
O.F. 32MM X 50/54 OD ACET LNR W/20 DEG
Smith & Nephew, Inc.
71927746
In Commercial Distribution

  • 00885556045695 ()
71927746

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

  • 00885556024669 ()
71343263

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

  • 00885556024003 ()
71342063

  • Ceramic acetabular liner
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