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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6.5mm Polyaxial Screw 35mm Dk Blue
CTL Medical Corporation
28-6500-035
In Commercial Distribution

  • 00841732151499 ()


  • Spinal bone screw, non-bioabsorbable
6.5mm Polyaxial Screw 30mm Dk Blue
CTL Medical Corporation
28-6500-030
In Commercial Distribution

  • 00841732151482 ()


  • Spinal bone screw, non-bioabsorbable
6.5mm Polyaxial Screw 25mm Dk Blue
CTL Medical Corporation
28-6500-025
In Commercial Distribution

  • 00841732151475 ()


  • Spinal bone screw, non-bioabsorbable
5.5mm Polyaxial Screw 55mm Lt Blue
CTL Medical Corporation
28-5500-055
In Commercial Distribution

  • 00841732151468 ()


  • Spinal bone screw, non-bioabsorbable
Osteotome Straight, 12
CTL Medical Corporation
91.001.1012
Not in Commercial Distribution

  • 90841732128111 ()


  • General internal orthopaedic fixation system implantation kit
MONET Plate, Medium, 2 Holes, H8mm "No Spikes"
CTL Medical Corporation
L.113.1208
Not in Commercial Distribution

  • 90841732128272 ()


  • Spinal fixation plate, non-bioabsorbable
A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
KRONUS, INC.
KR6275
In Commercial Distribution

  • B126KR62750 ()
KR6275

  • Thyroglobulin antibody IVD, kit, radioimmunoassay
A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
KRONUS, INC.
KR6270
In Commercial Distribution

  • B126KR62700 ()
KR6270

  • Thyroglobulin antibody IVD, kit, radioimmunoassay
ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria
BIOMERIEUX SA
ETEST® ESBL Cefotaxime/cefotaxime + clavulanic acid (CT/CTL)
In Commercial Distribution

  • 03573026624354 ()
  • 03573026624743 ()


  • Antibacterial minimum inhibitory concentration (MIC) IVD
Etest is a quantitative technique for determining the MIC of antimicrobial agents against microorganisms and for detection of resistance mechanisms.
BIOMERIEUX SA
ETEST® ESBL Cefotaxime/cefotaxime + clavulanic acid (CT/CTL)
In Commercial Distribution

  • 03573026256753 ()
  • 03573026548094 ()
  • 03573026547257 ()
  • 03573026256982 ()
  • 03573026548100 ()


  • Antibacterial minimum inhibitory concentration (MIC) IVD
Thyreoglobulin Recovery Sample - IMMULITE - CONS - 80 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381639
In Commercial Distribution

  • 00630414954523 ()
LTYRM

  • Thyroglobulin IVD, reagent
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)
No Description
MONOBIND, INC.
2225-300
In Commercial Distribution

  • 00816870021775 ()

  • Width: 7.75 Inch
2225-300B

  • Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
2225-300
In Commercial Distribution

  • 00816870021768 ()

  • Width: 7.75 Inch
2225-300A

  • Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
2275-300
In Commercial Distribution

  • 00816870023212 ()

  • Width: 7.75 Inch
2275-300B

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
No Description
MONOBIND, INC.
2275-300
In Commercial Distribution

  • 00816870023205 ()

  • Width: 7.75 Inch
2275-300A

  • Thyroglobulin IVD, kit, chemiluminescent immunoassay
The Quantitative Determination of Thyroglobulin (Tg) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Colorimetric.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-4110
In Commercial Distribution

  • 04048474041101 ()
EIA-4110

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
HbA1c (Hemoglobin A1c) control
CAROLINA LIQUID CHEMISTRIES CORPORATION
7-H7541-CTL
In Commercial Distribution

  • 00817302022162 ()

  • Total Volume: 0.5 Milliliter
  • Kit contains 1 control 1, 1 control 2 and 1 package insert
7-H7541-CTL

  • Glycated haemoglobin (HbA1c) IVD, control
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)
Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840724 ()
  • 04260764840571 ()

  • Fits for premature infants weighting 200-800g
24021703-S

  • Infant recumbent sleep positioner
Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840564 ()
  • 04260764840717 ()

  • Fits for premature infants weighting 800-2000g
24021703-M

  • Infant recumbent sleep positioner
Thyreoglobulin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381638
In Commercial Distribution

  • 00630414972077 ()
LKTY1(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Thyroglobulin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388175
In Commercial Distribution

  • 00630414979472 ()
LTYCVM

  • Thyroglobulin antibody IVD, control
No Description
USA INSTRUMENTS, INC.
1.5T 8 CHANNEL CTL COIL
In Commercial Distribution

  • 00840682120869 ()


  • MRI system coil, radio-frequency
No Description
USA INSTRUMENTS, INC.
1.5T 4 CHANNEL CTL COIL
In Commercial Distribution

  • 00840682120845 ()


  • MRI system coil, radio-frequency
VALIDATE THY2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: Tg Set: Thyroglobulin (Tg) TU Set: T-Uptake (TU)
Lgc Clinical Diagnostics, Inc.
908bc
In Commercial Distribution

  • 00850011135372 ()


  • Thyroglobulin IVD, control
  • Multiple thyroid hormone uptake (T-uptake) IVD, control
Compatible with Dentsply Sirona XiVE MP _ TG White Metal Scanmarker consisting of: 1x White Metal Scanmarker L15 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED4034L15
In Commercial Distribution

  • D800ZBED4034L15 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG White Metal Scanmarker consisting of: 1x White Metal Scanmarker L12 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED4034L12
In Commercial Distribution

  • D800ZBED4034L12 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG White Metal Scanmarker consisting of: 1x White Metal Scanmarker L15 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED4033L15
In Commercial Distribution

  • D800ZBED4033L15 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG White Metal Scanmarker consisting of: 1x White Metal Scanmarker L12 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED4033L12
In Commercial Distribution

  • D800ZBED4033L12 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG White Metal Scanmarker consisting of: 1x White Metal Scanmarker L15 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED4032L15
In Commercial Distribution

  • D800ZBED4032L15 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG White Metal Scanmarker consisting of: 1x White Metal Scanmarker L12 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED4032L12
In Commercial Distribution

  • D800ZBED4032L12 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG White Metal Scanmarker consisting of: 1x White Metal Scanmarker L15 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED4031L15
In Commercial Distribution

  • D800ZBED4031L15 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG White Metal Scanmarker consisting of: 1x White Metal Scanmarker L12 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED4031L12
In Commercial Distribution

  • D800ZBED4031L12 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840700 ()
  • 04260764840557 ()

  • Fits for premature infants weighting more than 2000g
24021703-L

  • Infant recumbent sleep positioner
The ZEUS AtheNA Multi-Lyte® TPO/Tg Plus Test System is intended for the quantitative detection of IgG class antibody to 2 separate Thyroid Antigens; Thyroid Peroxidase (TPO) and Thyroglobulin (Tg), in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune thyroid diseases. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A51101
In Commercial Distribution

  • 00845533000109 ()
A51101

  • Multiple thyroid antibody IVD, kit, fluorescent immunoassay
No Description
NT-Trading GmbH & Co. KG
UTG 80500000
Not in Commercial Distribution

  • ENTTUTG805000001 ()

  • Diameter: Ø 5,0 mm Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 80500000

  • Dental implant suprastructure, permanent, preformed
  • Dental prosthesis/implant abutment screw
No Description
NT-Trading GmbH & Co. KG
UTG 605000
Not in Commercial Distribution

  • ENTTUTG6050001 ()

  • Diameter: Ø 5,0 mm Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 605000

  • Dental implant suprastructure, permanent, preformed
  • Dental prosthesis/implant abutment screw
Collection of pathogen sample, lysis, and transportation while ensuring stability of DNA and RNA
Magbio Genomics, Inc.
MagBio CTL Medium VIRAL (500 mL)
In Commercial Distribution

  • 00850045030056 ()
MCTL-V500

  • Nucleic acid extraction/isolation kit IVD
Collection of pathogen sample, lysis, and transportation while ensuring stability of DNA and RNA
Magbio Genomics, Inc.
MagBio CTL Medium VIRAL (1000 mL)
In Commercial Distribution

  • 00850045030049 ()
MCTL-V1000

  • Nucleic acid extraction/isolation kit IVD
Collection of pathogen sample, lysis, and transportation while ensuring stability of DNA and RNA
Magbio Genomics, Inc.
MagBio CTL Medium MAX (500 mL)
In Commercial Distribution

  • 00850045030032 ()
MCTL-M500

  • Nucleic acid extraction/isolation kit IVD
Collection of pathogen sample, lysis, and transportation while ensuring stability of DNA and RNA
Magbio Genomics, Inc.
MagBio CTL Medium MAX (1000 mL)
In Commercial Distribution

  • 00850045030025 ()
MCTL-M1000

  • Nucleic acid extraction/isolation kit IVD
No Description
USA INSTRUMENTS, INC.
1.5T HD 4 CHANNEL CTL COIL
In Commercial Distribution

  • 00840682120852 ()


  • MRI system coil, radio-frequency
No Description
USA INSTRUMENTS, INC.
1.5T HD 8 CHANNEL CTL COIL
In Commercial Distribution

  • 00840682119818 ()


  • MRI system coil, radio-frequency
Thyroglobulin Sample Diluent - IMMULITE -- 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387046
In Commercial Distribution

  • 00630414954301 ()
LTYZ

  • Buffered sample diluent IVD
No Description
NT-Trading GmbH & Co. KG
UTG 80334200
Not in Commercial Distribution

  • ENTTUTG803342001 ()

  • Diameter: Ø 3,3 - 4,25 mm Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 80334200

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG 603342
Not in Commercial Distribution

  • ENTTUTG6033421 ()

  • Diameter: Ø 3,3 - 4,25 mm Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 603342

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: anti-thyroperoxidase TPO , anti-thyroglobulin TG , anti- TSH receptor R-TSH .
THERADIAG SA
THYRO
In Commercial Distribution

  • 03760170782072 ()
HM 065US-2X05

  • Multiple thyroid antibody IVD, control
Compatible with Dentsply Sirona XiVE MP _ TG Set consisting of: 1x Impression coping NON HEX 1x Screw for Impression coping 1x Cap for Impression coping closed tray
ZIRKONZAHN SRL
BSAQ4074
In Commercial Distribution

  • D800BSAQ4074 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Set consisting of: 1x Impression coping NON HEX 1x Screw for Impression coping 1x Cap for Impression coping closed tray
ZIRKONZAHN SRL
BSAQ4073
In Commercial Distribution

  • D800BSAQ4073 ()


  • Dental implant suprastructure, temporary, preformed, reusable
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