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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 - 00885556577264

54/28MM BH DUAL MOBILITY INSERT
Smith & Nephew, Inc.
74121654
In Commercial Distribution

  • 00885556577264 ()
74121654

  • Ceramic acetabular liner

BIRMINGHAM HIP - 00885556577257

52/28MM BH DUAL MOBILITY INSERT
Smith & Nephew, Inc.
74121652
In Commercial Distribution

  • 00885556577257 ()
74121652

  • Ceramic acetabular liner

BIRMINGHAM HIP - 00885556577240

50/28MM BH DUAL MOBILITY INSERT
Smith & Nephew, Inc.
74121650
In Commercial Distribution

  • 00885556577240 ()
74121650

  • Ceramic acetabular liner

BIRMINGHAM HIP - 00885556577233

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

  • 00885556577233 ()
74121648

  • Ceramic acetabular liner

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

ImmunoFA Toxoplasma IgG Conjugate - 00613745012025

IgG conjugate for use with ImmunoFA Toxoplasma IgG kit.
Genbio
800-1202
In Commercial Distribution

  • 00613745012025 ()

  • 3.5 mL
1202

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, reagent

AtheNA Multi-Lyte® HSV-1 & 2 IgG Plus Test System - 00845533000055

The ZEUS AtheNA Multi-Lyte® Herpes Simplex Virus (HSV)-1 & 2 IgG Plus Test System is intended for the qualitative detection of presence or absence of IgG antibodies to HSV-1 and HSV-2 in human serum. The test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and Herpes Simplex 2. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-1 and HSV-2. The test is not intended for donor screening or for self testing. The performance of this assay has not been established for use in a pediatric population, neonates, immunocompromised patients, for use by point of care facilities or for use with automated equipment. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A97101G
In Commercial Distribution

  • 00845533000055 ()
A97101G

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

Trinity Biotech - 05391516746496

Captia™ Herpes Group IgG
CLARK LABORATORIES, INC.
2346600
In Commercial Distribution

  • 05391516746496 ()

  • 96 Tests
2346600

  • 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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