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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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BIRMINGHAM HIP - 00885556577189

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

  • 00885556577189 ()
74121638

  • Ceramic acetabular liner

REFLECTION - 00885556535196

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

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

R3 ACETABULAR - 00885556022115

R3 36MM ID US CERAMIC ACET LINER MM56
Smith & Nephew, Inc.
71338956
In Commercial Distribution

  • 00885556022115 ()
71338956

  • Ceramic acetabular liner

NA - 00885556022054

ACETABULAR LINER 26MM Inner Diameter 63-70MM Outer Diameter 0 DEGREE
Smith & Nephew, Inc.
71340663
In Commercial Distribution

  • 00885556022054 ()
71340663

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556022047

R3 32MM ID US CERAMIC ACET LINER MM48
Smith & Nephew, Inc.
71338948
In Commercial Distribution

  • 00885556022047 ()
71338948

  • Ceramic acetabular liner

NA - 00885556021958

ACETABULAR LINER 22MMID 50-54MMOD 0 DEG
Smith & Nephew, Inc.
71342050
In Commercial Distribution

  • 00885556021958 ()
71342050

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556021927

R3 36MM ID US CERAMIC ACET LINER MM54
Smith & Nephew, Inc.
71338954
In Commercial Distribution

  • 00885556021927 ()
71338954

  • Ceramic acetabular liner

NA - 00885556021903

ACETABULAR LINER 32MM ID 56-62MM OD 0 DEGREE
Smith & Nephew, Inc.
71340256
In Commercial Distribution

  • 00885556021903 ()
71340256

  • Ceramic acetabular liner

NA - 00885556021880

ACETABULAR LINER 26MM ID 56-62MM OD 0 DEGREE
Smith & Nephew, Inc.
71340656
In Commercial Distribution

  • 00885556021880 ()
71340656

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556021750

R3 36MM ID US CERAMIC ACET LINER MM64
Smith & Nephew, Inc.
71338964
In Commercial Distribution

  • 00885556021750 ()
71338964

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556021552

R3 36MM ID US CERAMIC ACET LINER 52MM
Smith & Nephew, Inc.
71338952
In Commercial Distribution

  • 00885556021552 ()
71338952

  • Ceramic acetabular liner

REFLECTION - 00885556021453

ALUMINA CERAMIC LINER 32ID 56-66OD
Smith & Nephew, Inc.
71338456
Not in Commercial Distribution

  • 00885556021453 ()
71338456

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556021309

R3 36MM ID US CERAMIC ACET LINER MM62
Smith & Nephew, Inc.
71338962
In Commercial Distribution

  • 00885556021309 ()
71338962

  • Ceramic acetabular liner

REFLECTION - 00885556020975

ALUMINA CERAMIC LINER 32ID 50-54OD
Smith & Nephew, Inc.
71338450
Not in Commercial Distribution

  • 00885556020975 ()
71338450

  • Ceramic acetabular liner

NA - 00885556020906

ACETABULAR LINER 26MM Inner Diameter 50-54MM Outer Diameter 0 DEGREE
Smith & Nephew, Inc.
71340650
In Commercial Distribution

  • 00885556020906 ()
71340650

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556020685

R3 36MM ID US CERAMIC ACET LINER MM60
Smith & Nephew, Inc.
71338960
In Commercial Distribution

  • 00885556020685 ()
71338960

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556020661

R3 32MM ID US CERAMIC ACET LINER MM50
Smith & Nephew, Inc.
71338950
In Commercial Distribution

  • 00885556020661 ()
71338950

  • Ceramic acetabular liner

REFLECTION - 00885556020494

ALUMINA CERAMIC LINER 28ID 46-48OD
Smith & Nephew, Inc.
71338346
Not in Commercial Distribution

  • 00885556020494 ()
71338346

  • Ceramic acetabular liner

NA - 00885556020340

ACETABULAR LINER 26MM Inner Diameter 46-48MM Outer Diameter 0 DEGREE
Smith & Nephew, Inc.
71340646
In Commercial Distribution

  • 00885556020340 ()
71340646

  • Ceramic acetabular liner

REFLECTION - 00885556020104

REFLECTION XLPE 22 0 DEG LATERALIZED +4 42 B ETO
Smith & Nephew, Inc.
71334551
In Commercial Distribution

  • 00885556020104 ()
71334551

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556281444

R3 32MM ID US CERAMIC FORTE ACET LINER 58MM
Smith & Nephew, Inc.
71334858
In Commercial Distribution

  • 00885556281444 ()
71334858

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556281390

R3 32MM ID US CERAMIC FORTE ACET LINER 56MM
Smith & Nephew, Inc.
71334856
In Commercial Distribution

  • 00885556281390 ()
71334856

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556274965

R3 32MM ID US CERAMIC FORTE ACET LINER 54MM
Smith & Nephew, Inc.
71334854
In Commercial Distribution

  • 00885556274965 ()
71334854

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556274910

R3 32MM ID US CERAMIC FORTE ACET LINER 52MM
Smith & Nephew, Inc.
71334852
In Commercial Distribution

  • 00885556274910 ()
71334852

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556274866

R3 28MM ID US CERAMIC FORTE ACET LINER 50MM
Smith & Nephew, Inc.
71334850
In Commercial Distribution

  • 00885556274866 ()
71334850

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556274415

R3 28MM ID US CERAMIC FORTE ACET LINER 48MM
Smith & Nephew, Inc.
71334848
In Commercial Distribution

  • 00885556274415 ()
71334848

  • Ceramic acetabular liner

R3 - 00885556192030

R3 20 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 66/70MM
Smith & Nephew, Inc.
71934558
In Commercial Distribution

  • 00885556192030 ()
71934558

  • Ceramic acetabular liner

R3 - 00885556191989

R3 20 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 64MM
Smith & Nephew, Inc.
71934557
In Commercial Distribution

  • 00885556191989 ()
71934557

  • Ceramic acetabular liner

R3 - 00885556498996

R3 36MM INNER DIAMETER US DELTA LINER 66 68MM OUTER DIAMETER
Smith & Nephew, Inc.
71325166
In Commercial Distribution

  • 00885556498996 ()
71325166

  • Ceramic acetabular liner

BIOLOX delta - 00885556498941

R3 36MM ID US DELTA LINER 64MM OD
Smith & Nephew, Inc.
71325164
In Commercial Distribution

  • 00885556498941 ()
71325164

  • Ceramic acetabular liner

BIOLOX delta - 00885556498897

R3 36MM ID US DELTA LINER 62MM OD
Smith & Nephew, Inc.
71325162
In Commercial Distribution

  • 00885556498897 ()
71325162

  • Ceramic acetabular liner

BIOLOX delta - 00885556498842

R3 36MM ID US DELTA LINER 60MM OD
Smith & Nephew, Inc.
71325160
In Commercial Distribution

  • 00885556498842 ()
71325160

  • Ceramic acetabular liner

BIOLOX delta - 00885556498798

R3 36MM ID US DELTA LINER 58MM OD
Smith & Nephew, Inc.
71325158
In Commercial Distribution

  • 00885556498798 ()
71325158

  • Ceramic acetabular liner

BIOLOX delta - 00885556498743

R3 36MM ID US DELTA LINER 56MM OD
Smith & Nephew, Inc.
71325156
In Commercial Distribution

  • 00885556498743 ()
71325156

  • Ceramic acetabular liner

BIOLOX delta - 00885556498699

R3 36MM ID US DELTA LINER 54MM OD
Smith & Nephew, Inc.
71325154
In Commercial Distribution

  • 00885556498699 ()
71325154

  • Ceramic acetabular liner

BIOLOX delta - 00885556498644

R3 36MM ID US DELTA LINER 52MM OD
Smith & Nephew, Inc.
71325152
In Commercial Distribution

  • 00885556498644 ()
71325152

  • Ceramic acetabular liner

R3 - 00885556498590

R3 32MM INNER DIAMETER US DELTA LINER 50MM OUTER DIAMETER
Smith & Nephew, Inc.
71325150
In Commercial Distribution

  • 00885556498590 ()
71325150

  • Ceramic acetabular liner

R3 - 00885556498545

R3 32MM INNER DIAMETER US DELTA LINER 48MM OUTER DIAMETER
Smith & Nephew, Inc.
71325148
In Commercial Distribution

  • 00885556498545 ()
71325148

  • Ceramic acetabular liner

SeraQuest - 00850487007333

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
HSV G
In Commercial Distribution

  • 00850487007333 ()
Q01-160

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ReQuest - 00850487007142

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
HSV G
In Commercial Distribution

  • 00850487007142 ()
Q01-160

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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