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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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Carnegie Surgical LLC - G1414045920

Spare lamp for conventional laryngoscope reusable blades, large (fits MAC 1-5, Flexible 2-4 & MIL 2-4 blades)
Carnegie Surgical LLC
404-592
In Commercial Distribution

  • G1414045920 ()
404-592

  • Laryngoscope blade, reusable

Detecto - 00809161137408

Bariatric Scale, Digital, 1000 lb x .2 lb / 450kg x .1 kg, 24" x 24" Platform
CARDINAL SCALE MANUFACTURING COMPANY
6856
In Commercial Distribution

  • 00809161137408 ()


  • Stand-on floor scale, electronic

ELISA Tg IgG Smart Kit Test System - 00845533001182

The ZEUS ELISA Thyroglobulin (Tg) IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibody to thyroglobulin in human serum. The test system is intended to be used as an aid in the diagnosis of thyroid diseases. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM2Z5061G
In Commercial Distribution

  • 00845533001182 ()
SM2Z5061G

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)

IMMULITE® Systems TG Recovery Sample Thyroglobulin - 00630414954523

Thyreoglobulin Recovery Sample - IMMULITE - CONS - 80 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381639
In Commercial Distribution

  • 00630414954523 ()
LTYRM

  • Thyroglobulin IVD, reagent

Tg AccuBind ELISA Test System - 96 Wells - 00816870021768

No Description
MONOBIND, INC.
2225-300
In Commercial Distribution

  • 00816870021768 ()

  • Width: 7.75 Inch
2225-300A

  • Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)

Tg AccuLite CLIA Test System - 192 Wells - 00816870023212

No Description
MONOBIND, INC.
2275-300
In Commercial Distribution

  • 00816870023212 ()

  • Width: 7.75 Inch
2275-300B

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay

Monobind AccuLite Tg CLIA Kit - 96 Wells - 00816870023205

No Description
MONOBIND, INC.
2275-300
In Commercial Distribution

  • 00816870023205 ()

  • Width: 7.75 Inch
2275-300A

  • Thyroglobulin IVD, kit, chemiluminescent immunoassay

Tg AccuBind ELISA Test System - 192 Wells - 00816870021775

No Description
MONOBIND, INC.
2225-300
In Commercial Distribution

  • 00816870021775 ()

  • Width: 7.75 Inch
2225-300B

  • Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Thyroglobulin (Anti-Tg) ELISA - 00840239041104

The Quantitative Determination of Thyroglobulin (Tg) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Colorimetric. Measurements of Tg autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto’s and Grave’s as well as nontoxic goiter.
DRG International Inc
EIA-4110
In Commercial Distribution

  • 00840239041104 ()

  • Total Volume: 20 Milliliter
  • Wash Solution
  • Calibrators
  • Total Volume: 13 Milliliter
  • Stop Solution
  • Total Volume: 1 Milliliter
  • Substrate B
  • Biotin Reagent
  • Substrate A
  • Total Volume: 7 Milliliter
  • Enzyme Reagent
  • Total Volume: 8 Milliliter
  • Serum Diluent
EIA-4110

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)

RIM-LOC HIP SYSTEM - 00880304191655

No Description
Biomet Orthopedics, LLC
105424
In Commercial Distribution

  • 00880304191655 ()

  • 24 SIZE
105424

  • Acetabular shell

INSERTER PLATE W/POST - 00880304009288

No Description
Biomet Orthopedics, LLC
423694
In Commercial Distribution

  • 00880304009288 ()

  • 24 MM
423694

  • Orthopaedic inorganic implant inserter/extractor, reusable

RINGLOC + HIP SYSTEM - 00880304455078

No Description
Biomet Orthopedics, LLC
106024
In Commercial Distribution

  • 00880304455078 ()

  • 24 SIZE
106024

  • Acetabular shell

Compress Device - 00880304461642

No Description
Biomet Orthopedics, LLC
178566
In Commercial Distribution

  • 00880304461642 ()

  • 24 MM
178566

  • Knee femur stem prosthesis

MEDALLION MODULAR HIP SYSTEM - 00880304640047

No Description
Biomet Orthopedics, LLC
71-007001
In Commercial Distribution

  • 00880304640047 ()

  • 24 MM
71-007001

  • Uncoated hip femur prosthesis, modular

Arcos® Modular Revision Hip System - 00880304474352

No Description
Biomet Orthopedics, LLC
11-302124
In Commercial Distribution

  • 00880304474352 ()

  • 24 MM
11-302124

  • Coated femoral stem prosthesis, modular

ARCOS MODULAR REVISION SYSTEM - 00880304496873

No Description
Biomet Orthopedics, LLC
31-300574
In Commercial Distribution

  • 00880304496873 ()

  • SIZE 24
31-300574

  • Bone-resection orthopaedic reamer, reusable

PEANUT PLATING SYSTEM - 00880304492530

No Description
Biomet Orthopedics, LLC
24524
In Commercial Distribution

  • 00880304492530 ()

  • 24 MM
24524

  • Orthopaedic bone screw, non-bioabsorbable, sterile

RING RETAINER - 00880304567863

No Description
Biomet Orthopedics, LLC
110005138
In Commercial Distribution

  • 00880304567863 ()

  • SIZE 24
110005138

  • Orthopaedic implant impactor, reusable

RINGLOC(R) ACETABULAR IMPACTOR PLATE - 00880304371156

No Description
Biomet Orthopedics, LLC
423334
In Commercial Distribution

  • 00880304371156 ()

  • SIZE 24
423334

  • Orthopaedic implant impactor, reusable

Alexis Wound Protector-Retractor - 00607915132958

Wound Retractor and Protector
APPLIED MEDICAL RESOURCES CORPORATION
C8322
In Commercial Distribution

  • 10607915132955 ()
  • 00607915132958 ()

  • 2-4 cm


  • Radial surgical retractor

Alexis Wound Protector-Retractor - 00607915117245

Wound Retractor and Protector
APPLIED MEDICAL RESOURCES CORPORATION
C8312
In Commercial Distribution

  • 10607915117242 ()
  • 00607915117245 ()

  • 2-4 cm


  • Radial surgical retractor

MONOFLUO - 00847865001519

MONOFLUO Pneumocystis jirovecii (P. carinii) IFA Test
Bio-RAD Laboratories, Inc.
32515
In Commercial Distribution

  • 00847865001519 ()

  • 24 Tests
32515

  • Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT)

Kallestad - 00847865001496

MONOFLUO Legionella pneumophila IFA Test Kit
Bio-RAD Laboratories, Inc.
32514
In Commercial Distribution

  • 00847865001496 ()

  • 24 Tests
32514

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

RINGLOC + INSTRUMENTATION - 05019279415328

No Description
Biomet Uk Ltd
31-400624
In Commercial Distribution

  • 05019279415328 ()

  • SIZE 24
31-400624

  • Orthopaedic implant impactor, reusable

GenetiSure Dx Hybridization Kit - 05700571112625

GenetiSure Dx Hybridization Kit
AGILENT TECHNOLOGIES, INC.
K1201-64200
In Commercial Distribution

  • 05700571112625 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)

GenetiSure Dx Labeling Kit Purification Columns - 05700571112618

GenetiSure Dx Labeling Kit Purification Columns
AGILENT TECHNOLOGIES, INC.
K1201-64110
In Commercial Distribution

  • 05700571112618 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)

GenetiSure Dx Labeling Kit - 05700571112601

GenetiSure Dx Labeling Kit
AGILENT TECHNOLOGIES, INC.
K1201-64105
In Commercial Distribution

  • 05700571112601 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)

GenetiSure Dx Postnatal Assay - 05700571108697

GenetiSure Dx Postnatal Assay
AGILENT TECHNOLOGIES, INC.
K1201A
In Commercial Distribution

  • 05700571108697 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)

Sierra™ - 10889910059141

S2S CrossBar, 24 - 29mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-2021
Not in Commercial Distribution

  • 10889910059141 ()

  • 24 - 29mm
50-2021

  • Vertebral body prosthesis, non-sterile

ACRYSOF® - 00380652249973

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 1.50 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT3
In Commercial Distribution

  • 00380652249973 ()

  • Diopter 24
SN6AT3.240

  • Posterior-chamber intraocular lens, pseudophakic
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